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Regulatory Affairs & Quality Specialist at Siemens
, , United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Quality Management, Iso 13485, Fda Regulations, European Directives, In Vitro Diagnostics, Problem Solving, Communication, Organizational Skills, Self Discipline, Team Player, Accuracy, Microsoft Office, Field Actions, Compliance, Reporting
Specialization
Knowledge of compliance with international standards and regulatory requirements is essential, along with a degree in a relevant discipline or equivalent experience. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, is required.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Assistent/in (m/w/d) at Pentel BrobedarfHandelsgesellschaft mbH
22339 Hamburg, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Business and Government Affairs Manager at Soelect Inc
Greensboro, NC 27410, USA - Full Time
Skills Needed
Interpersonal Skills, Manufacturing Processes, Financial Concepts, Working Environment
Qualification
BSc
Manager/Sr. Manager, Regulatory Affairs at Arrowhead Pharmaceuticals
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Project Management, Communication, Negotiation, Regulatory Compliance, Technical Documentation, Rna Interference, Clinical Protocols, International Submissions, Ich Guidelines, Fda Guidelines, Veeva Rim, Smartsheets, Attention To Detail, Team Collaboration, Research, Analysis
Specialization
Candidates should have a BS or MS with 5 years of regulatory experience, or a PharmD/PhD with 3 years of experience. Experience with international regulatory submissions and knowledge of ICH and FDA guidelines is essential.
Experience Required
Minimum 5 year(s)
Admin Legal Affairs - Only UAE National at Talabat
Dubai, , United Arab Emirates - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Regulatory & Affairs Mitarbeiter (m/w/d) at MANI MEDICAL GERMANY GmbH
6RVDH, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Clinical Affairs Training Specialist, EU at RxSight, Inc.
Munich, Bavaria, Germany - Full Time
Skills Needed
Clinical Experience, Ophthalmic Industry, Communication Skills, Cataract Surgery, Training, Customer Support, Data Collection, Problem Solving, Team Collaboration, Patient Safety, Regulatory Compliance, Clinical Evaluations, Light Adjustable Lens, Onboarding, Monitoring, Auditing
Specialization
Candidates must have 6+ years of clinical experience in the ophthalmic industry and strong communication skills. Fluency in German, French, or Spanish is required, along with the ability to travel frequently throughout Europe.
Experience Required
Minimum 5 year(s)
Clinical Affairs Training Specialist, EU at RxSight, Inc.
Frankfurt, Hesse, Germany - Full Time
Skills Needed
Clinical Experience, Ophthalmic Industry, Communication Skills, Cataract Surgery, Patient Evaluation, Training, Customer Support, Data Collection, Regulatory Compliance, Team Collaboration, Problem Solving, Fluency In German, Fluency In French, Fluency In Spanish, Light Adjustable Lens, Good Clinical Practice, Onboarding
Specialization
Candidates should have 6+ years of clinical experience in the ophthalmic industry and a strong understanding of cataract surgery. Fluency in at least one of the following languages: German, French, or Spanish is required.
Experience Required
Minimum 5 year(s)
Public Affairs and Engagement Specialist at Adecco Canada
Spruce Grove, AB, Canada - Full Time
Skills Needed
Event Planning, Stakeholder Engagement, Interpersonal Skills, Communications, Public Affairs, Platforms
Specialization
Communications public affairs or a related field
Qualification
Graduate
Scientist, Global Regulatory Affairs CMC at Lundbeck
København, , Denmark - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Counsel - Licensing & Affairs at Adyen
Berlin, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 7 year(s)
SEN Teacher - Head of Department at CareTech Group
Yeovil, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Fulfillment Department Supervisor at Lowe's Companies, Inc.
Jackson, Tennessee, United States - Full Time
Skills Needed
Team Leadership, Operational Excellence, Customer Service, Performance Coaching, Safety Management, Problem Solving, Inventory Management, Cross Functional Training, Communication, Coaching, Staffing, Process Improvement, Time Management, Decision Making, Conflict Resolution, Analytical Skills
Specialization
The position requires strong leadership skills and the ability to manage operational processes effectively. Experience in customer service and team management is essential.
Experience Required
Minimum 2 year(s)
Deli Department Clerk - Part Time at Ridley’s Family Markets
Weiser, Idaho, United States - Full Time
Skills Needed
Customer Relations, Communication, Deli Production, Teamwork, Coaching, Record Keeping, Morale Building, Sales Improvement
Specialization
Candidates should possess knowledge of deli production fundamentals and be able to teach these skills to others. A high level of productivity and adherence to company policies is essential.
Staff Bookkeeper- Tax Department at BPM LLP
, , United States - Full Time
Skills Needed
Bookkeeping, Quickbooks, Intacct, Attention To Detail, Communication Skills, Accounts Payable, Customer Invoicing, Bank Reconciliations, Tax Compliance, General Ledger, Process Improvements, Accrual Accounting, Cash Basis Accounting, Client Onboarding, Compliance Filings, Pro Advisor Certification
Specialization
The ideal candidate should have 5+ years of bookkeeping experience and proficiency with accounting software like QuickBooks and Intacct. Excellent attention to detail and communication skills are essential.
Experience Required
Minimum 5 year(s)
Deli Department Assistant Manager at Ridley’s Family Markets
Gypsum, Colorado, United States - Full Time
Skills Needed
Leadership, Analytical Skills, Guest Service Skills, Verbal Communication, Written Communication, Problem Solving, Organizational Skills, Team Development, Attention To Detail, Flexibility, Deli Equipment Knowledge, Sales Skills, Product Knowledge, Complaint Resolution, Time Management, Merchandising
Specialization
Candidates should have a high school diploma and 1-3 years of retail experience. Strong leadership, communication, and problem-solving skills are essential, along with the ability to work flexible hours.
Experience Required
Minimum 2 year(s)
Melt and EP Departmental Manager at Adept Resourcing UK
Sheffield, England, United Kingdom - Full Time
Skills Needed
Manufacturing Processes, Six Sigma, Microsoft Office
Qualification
Graduate
Sales Manager - Sales Department at Hotel Okura Amsterdam
1AZ, , Netherlands - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Breaker Department Lead 2nd Shift at Forsman Farms
Howard Lake, Minnesota, United States - Full Time
Skills Needed
Team Leadership, Training, Quality Control, Process Improvement, Communication, Safety Regulations, Problem Solving, Dependability, Self Motivation, Adaptability, Performance Monitoring, Gmp Compliance, Ppe Usage, Task Management, Hazard Awareness, Workflow Direction
Specialization
Candidates should be able to work independently and lead a team while adapting to changing circumstances in a fast-paced environment. Strong communication skills and the ability to identify and implement process improvements are essential.
Experience Required
Minimum 2 year(s)
Rental Department Supervisor - MM at Marquette Mountain Resort LLC
Marquette, Michigan, United States - Full Time
Skills Needed
Supervision, Customer Service, Staff Management, Scheduling, Problem Solving, Equipment Fitting, Training, Inventory Control, Communication, Organizational Skills, Manual Labor, Safety Protocols, Loss Prevention, Collaboration, Equipment Maintenance, Adaptability
Specialization
Candidates must have a high school diploma and at least two years of experience in the mountain bike or ski area industry. Strong communication skills, organizational abilities, and knowledge of ski/snowboard equipment are essential.
Experience Required
Minimum 2 year(s)
Regulatory Affairs & Quality Specialist at Siemens
, , United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Quality Management, ISO 13485, FDA Regulations, European Directives, In Vitro Diagnostics, Problem Solving, Communication, Organizational Skills, Self-Discipline, Team Player, Accuracy, Microsoft Office, Field Actions, Compliance, Reporting

Industry

Automation Machinery Manufacturing

Description
Regulatory Affairs & Quality Specialist - Home Based - ***FIXED TERM CONTRACT UNTIL END OF DECEMBER 2026*** Now’s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Do you have regulatory experience, and are you seeking a new job? Siemens Healthineers is looking for a full-time Regulatory Affairs Specialist on a Fixed Term Contract basis until the end of 2026 to cover a period of maternity leave, offering a competitive salary and benefits package and the opportunity to further build your experience in a leading organisation. As a Regulatory Affairs Specialist, you will provide regulatory support to the European Authorised Representative (EU AR) team on a day to day basis. This role reports to and supports the EU Authorised Representative Manager to ensure compliance to the requirements of IVDR Regulation (EU) 2017/746, UK regulation (MDR 2002), as well as other relevant global regulatory framework. This team works closely with other departments providing regulatory / quality support in a manner that is consistent with the company's Business Principles. Your Role: In relation to OUS Field Actions for the Diagnostics Business Line, liaise with legal Manufacturers and country Quality Teams, provide reporting recommendation, review approve and distribute documents. To provide Diagnostics Quality with feedback / questions and ensure closure for each Field Action. Where applicable, to complete reporting activities in accordance with IVDR Article 87(7) and UK MDR (Regulations 44ZJ and Regulation 44ZK) Co-ordinate OUS Field Action enquiries Be a Point of Contact for EU AR / UK Responsible Person on behalf of the US & UK legal Manufacturers Your Experience: To apply for this role, you will need knowledge of compliance with key international standards (i.e. ISO 13485, FDA regulations, European Directives and Regulations) and with regulatory requirements worldwide (preferable but not mandatory) Degree qualification in a relevant discipline (Regulatory Affairs or Quality degree is desirable but not mandatory) and/or appropriate professional experience gained working in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, although other medical devices background will also be considered Proficient in Microsoft Office (including Outlook, Excel, Word, SharePoint, etc) Promote excellence and embrace right first time culture. A strong understanding of the need for accuracy Work efficiently and be self-disciplined To work well under pressure and to be able to identify the need to prioritise when required To be a dynamic team player who displays problem solving skills, who can work effectively and proactively on activities both individually and within a team Good communicator fluent in English in both speaking and writing with strong organisational skills Benefits: Competitive basic salary Up to 10% matched pension contributions BUPA Private Medical Cover Bonus Share Save Scheme 26 days annual leave (with the option to buy/sell up to 5) + bank holidays A range of additional salary sacrifice benefits including EV car scheme, global travel insurance and dental cover to name a few How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
Responsibilities
Provide regulatory support to the EU Authorised Representative team and ensure compliance with IVDR Regulation and UK regulations. Liaise with legal manufacturers and country quality teams regarding OUS Field Actions and coordinate inquiries.
Regulatory Affairs & Quality Specialist at Siemens
, , United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Quality Management, Iso 13485, Fda Regulations, European Directives, In Vitro Diagnostics, Problem Solving, Communication, Organizational Skills, Self Discipline, Team Player, Accuracy, Microsoft Office, Field Actions, Compliance, Reporting
Specialization
Knowledge of compliance with international standards and regulatory requirements is essential, along with a degree in a relevant discipline or equivalent experience. Proven experience in a regulatory role, preferably in the in-vitro diagnostics industry, is required.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Assistent/in (m/w/d) at Pentel BrobedarfHandelsgesellschaft mbH
22339 Hamburg, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Business and Government Affairs Manager at Soelect Inc
Greensboro, NC 27410, USA - Full Time
Skills Needed
Interpersonal Skills, Manufacturing Processes, Financial Concepts, Working Environment
Qualification
BSc
Manager/Sr. Manager, Regulatory Affairs at Arrowhead Pharmaceuticals
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Project Management, Communication, Negotiation, Regulatory Compliance, Technical Documentation, Rna Interference, Clinical Protocols, International Submissions, Ich Guidelines, Fda Guidelines, Veeva Rim, Smartsheets, Attention To Detail, Team Collaboration, Research, Analysis
Specialization
Candidates should have a BS or MS with 5 years of regulatory experience, or a PharmD/PhD with 3 years of experience. Experience with international regulatory submissions and knowledge of ICH and FDA guidelines is essential.
Experience Required
Minimum 5 year(s)
Admin Legal Affairs - Only UAE National at Talabat
Dubai, , United Arab Emirates - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Regulatory & Affairs Mitarbeiter (m/w/d) at MANI MEDICAL GERMANY GmbH
6RVDH, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Clinical Affairs Training Specialist, EU at RxSight, Inc.
Munich, Bavaria, Germany - Full Time
Skills Needed
Clinical Experience, Ophthalmic Industry, Communication Skills, Cataract Surgery, Training, Customer Support, Data Collection, Problem Solving, Team Collaboration, Patient Safety, Regulatory Compliance, Clinical Evaluations, Light Adjustable Lens, Onboarding, Monitoring, Auditing
Specialization
Candidates must have 6+ years of clinical experience in the ophthalmic industry and strong communication skills. Fluency in German, French, or Spanish is required, along with the ability to travel frequently throughout Europe.
Experience Required
Minimum 5 year(s)
Clinical Affairs Training Specialist, EU at RxSight, Inc.
Frankfurt, Hesse, Germany - Full Time
Skills Needed
Clinical Experience, Ophthalmic Industry, Communication Skills, Cataract Surgery, Patient Evaluation, Training, Customer Support, Data Collection, Regulatory Compliance, Team Collaboration, Problem Solving, Fluency In German, Fluency In French, Fluency In Spanish, Light Adjustable Lens, Good Clinical Practice, Onboarding
Specialization
Candidates should have 6+ years of clinical experience in the ophthalmic industry and a strong understanding of cataract surgery. Fluency in at least one of the following languages: German, French, or Spanish is required.
Experience Required
Minimum 5 year(s)
Public Affairs and Engagement Specialist at Adecco Canada
Spruce Grove, AB, Canada - Full Time
Skills Needed
Event Planning, Stakeholder Engagement, Interpersonal Skills, Communications, Public Affairs, Platforms
Specialization
Communications public affairs or a related field
Qualification
Graduate
Scientist, Global Regulatory Affairs CMC at Lundbeck
København, , Denmark - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Counsel - Licensing & Affairs at Adyen
Berlin, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 7 year(s)
SEN Teacher - Head of Department at CareTech Group
Yeovil, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Fulfillment Department Supervisor at Lowe's Companies, Inc.
Jackson, Tennessee, United States - Full Time
Skills Needed
Team Leadership, Operational Excellence, Customer Service, Performance Coaching, Safety Management, Problem Solving, Inventory Management, Cross Functional Training, Communication, Coaching, Staffing, Process Improvement, Time Management, Decision Making, Conflict Resolution, Analytical Skills
Specialization
The position requires strong leadership skills and the ability to manage operational processes effectively. Experience in customer service and team management is essential.
Experience Required
Minimum 2 year(s)
Deli Department Clerk - Part Time at Ridley’s Family Markets
Weiser, Idaho, United States - Full Time
Skills Needed
Customer Relations, Communication, Deli Production, Teamwork, Coaching, Record Keeping, Morale Building, Sales Improvement
Specialization
Candidates should possess knowledge of deli production fundamentals and be able to teach these skills to others. A high level of productivity and adherence to company policies is essential.
Staff Bookkeeper- Tax Department at BPM LLP
, , United States - Full Time
Skills Needed
Bookkeeping, Quickbooks, Intacct, Attention To Detail, Communication Skills, Accounts Payable, Customer Invoicing, Bank Reconciliations, Tax Compliance, General Ledger, Process Improvements, Accrual Accounting, Cash Basis Accounting, Client Onboarding, Compliance Filings, Pro Advisor Certification
Specialization
The ideal candidate should have 5+ years of bookkeeping experience and proficiency with accounting software like QuickBooks and Intacct. Excellent attention to detail and communication skills are essential.
Experience Required
Minimum 5 year(s)
Deli Department Assistant Manager at Ridley’s Family Markets
Gypsum, Colorado, United States - Full Time
Skills Needed
Leadership, Analytical Skills, Guest Service Skills, Verbal Communication, Written Communication, Problem Solving, Organizational Skills, Team Development, Attention To Detail, Flexibility, Deli Equipment Knowledge, Sales Skills, Product Knowledge, Complaint Resolution, Time Management, Merchandising
Specialization
Candidates should have a high school diploma and 1-3 years of retail experience. Strong leadership, communication, and problem-solving skills are essential, along with the ability to work flexible hours.
Experience Required
Minimum 2 year(s)
Melt and EP Departmental Manager at Adept Resourcing UK
Sheffield, England, United Kingdom - Full Time
Skills Needed
Manufacturing Processes, Six Sigma, Microsoft Office
Qualification
Graduate
Sales Manager - Sales Department at Hotel Okura Amsterdam
1AZ, , Netherlands - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Breaker Department Lead 2nd Shift at Forsman Farms
Howard Lake, Minnesota, United States - Full Time
Skills Needed
Team Leadership, Training, Quality Control, Process Improvement, Communication, Safety Regulations, Problem Solving, Dependability, Self Motivation, Adaptability, Performance Monitoring, Gmp Compliance, Ppe Usage, Task Management, Hazard Awareness, Workflow Direction
Specialization
Candidates should be able to work independently and lead a team while adapting to changing circumstances in a fast-paced environment. Strong communication skills and the ability to identify and implement process improvements are essential.
Experience Required
Minimum 2 year(s)
Rental Department Supervisor - MM at Marquette Mountain Resort LLC
Marquette, Michigan, United States - Full Time
Skills Needed
Supervision, Customer Service, Staff Management, Scheduling, Problem Solving, Equipment Fitting, Training, Inventory Control, Communication, Organizational Skills, Manual Labor, Safety Protocols, Loss Prevention, Collaboration, Equipment Maintenance, Adaptability
Specialization
Candidates must have a high school diploma and at least two years of experience in the mountain bike or ski area industry. Strong communication skills, organizational abilities, and knowledge of ski/snowboard equipment are essential.
Experience Required
Minimum 2 year(s)