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Regulatory Affairs Consultant at DLRC
Letchworth, England, United Kingdom - Full Time
Skills Needed
Life Sciences, Regulatory Affairs
Qualification
BSc
Regulatory Affairs Associate at Career Connections Canada Inc
Mississauga, ON, Canada - Full Time
Skills Needed
Computer Skills, Adobe Acrobat, Regulatory Affairs, Communication Skills, Chemistry, Analytical Skills, Dental Care, It, Harmonization
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at PRESTIGE BIOPHARMA LIMITED
Singapore, , Singapore - Full Time
Skills Needed
Chemistry, Regulatory Affairs, English, Clinical Trials
Specialization
Chemistry
Qualification
Graduate
Regulatory Affairs Specialist at OrthoPediatrics
Warsaw, Indiana, United States - Full Time
Skills Needed
Regulatory Strategy, Technical Writing, Communication Skills, Project Management, Medical Device Regulations, Verification And Validation, Database Management, Labeling Compliance, Problem Solving, Team Collaboration, Product Development, Regulatory Submissions, Change Assessment, Testing Requirements, Documentation Review, Regulatory Procedures
Specialization
Candidates should have a fundamental understanding of medical device terminology and regulations, along with excellent technical writing and communication skills. A bachelor's degree and a minimum of 2 years of experience in regulatory affairs for medical devices are preferred.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Kerecis LLC
Minneapolis, Minnesota, United States - Full Time
Skills Needed
Regulatory Affairs, Fda Applications, Regulatory Strategies, Document Drafting, Risk Assessment, Analytical Skills, Problem Solving, Communication Skills, Team Collaboration, Medical Device Development, Iso Requirements, Product Development, Testing Protocols, Attention To Detail, Microsoft Office, Creative Thinking
Specialization
Candidates should have a bachelor's degree in Engineering or a related field and at least 5 years of experience in the Medical Device field. Experience in regulatory roles supporting pre-market product development is also required.
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Regulatory Affairs, Adobe Acrobat, Analytical Skills, Computer Skills, Dental Care, Communication Skills, It, Harmonization, Chemistry
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Specialist at CooperSurgical
Remote, Scotland, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Specialization
Relevant Field
Qualification
MSc
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at NDR Medical Technology Pte Ltd
Singapore 139953, , Singapore - Full Time
Skills Needed
Interpersonal Skills, Device Development, Presentation Skills, Timelines
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Government Affairs Lead, Gulf at Amgen
Dubai, , United Arab Emirates - Full Time
Skills Needed
External Relationships, Communication Skills, Internal Customers, Strategic Counsel
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr Manager Regulatory Affairs at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Samd Regulations, Fda Guidance, Iso Standards, Technical Documentation, Team Management, Digital Health Products, Cybersecurity, Data Privacy, Software Development, Ai/Ml Technologies, Agile Methodologies, Change Management, Product Classification, Regulatory Submissions, Quality Assurance
Specialization
Candidates typically require a Bachelor’s degree and 13+ years of relevant experience in the medical device industry, including 5-8 years of people management experience. A minimum of 5 years of regulatory affairs experience is also required.
Experience Required
Minimum 10 year(s)
Graduate - Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands
London, England, United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Communication, Teamwork, Initiative, Proactivity, Academic Curiosity, Integrity, Transparency, Accountability, Diversity, Inclusivity, Regulatory Strategy, Regulatory Compliance, Life Cycle Maintenance, Health Authority Interactions, Operational Excellence
Specialization
Candidates should have a degree in relevant fields such as Pharmacy, Chemical Engineering, or Biology. The program is open to students based in the UK who complete their undergraduate degree between 2024 and 2026.
Regulatory Affairs Specialist at OrganOx
Oxford, England, United Kingdom - Full Time
Skills Needed
Management System, Regulatory Affairs, Regulatory Submissions, Organization Skills, Documentation, Microsoft Word, Excel, Maintenance
Qualification
Graduate
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Adobe Acrobat, It, Dental Care, Communication Skills, Computer Skills, Analytical Skills, Chemistry, Harmonization, Regulatory Affairs
Qualification
BSc
Experience Required
Minimum 5 year(s)
Public Affairs Community Lead at Roche
Welwyn, England, United Kingdom - Full Time
Skills Needed
Government Officials, Public Affairs
Qualification
Graduate
Regulatory Affairs Specialist at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Medical Device, Software Development, Technical Documentation, Cross Functional Collaboration, Risk Assessment, Fda Regulations, Iso Standards, Agile Methodologies, Digital Health, Ai Technologies, Mobile Development, Cloud Based Solutions, Change Assessment, Validation Activities, Product Labeling
Specialization
Candidates should have experience in medical device design and development processes, along with knowledge of relevant regulations and standards. Excellent writing and communication skills are essential, as well as experience in a cross-functional environment.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at Hyperfine
Guilford, Connecticut, USA - Full Time
Skills Needed
Regulatory Affairs, Regulatory Submissions, Emerging Technologies, Medical Imaging, Regulations, Outlook, Nomenclature, Communication Skills, Excel
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Associate at Katalyst Healthcares Life Sciences
Columbia, MD 20588, USA - Full Time
Skills Needed
Regulatory Affairs, Medical Devices, Manufacturing
Specialization
Chemical
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialist at Heidi Health
Melbourne, Victoria, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist at Sysmex UK
Milton Keynes, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Public Affairs Manager at Lalamove
Manila, Metro Manila, Philippines - Full Time
Skills Needed
Public Policy, Government Relations, Stakeholder Engagement, Research, Strategic Communications, Partnership Development, Regulatory Compliance, Esg Strategies
Specialization
Candidates should have a degree or master's degree in public policy and experience with local and national government agencies. They must also have experience in strategic communications and partnership plans.
Experience Required
Minimum 5 year(s)
Regulatory Affairs Consultant at DLRC
Letchworth, England, United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

02 Dec, 25

Salary

0.0

Posted On

02 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Life Sciences, Regulatory Affairs

Industry

Pharmaceuticals

Description

Established in 2005, DLRC Ltd has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.
Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.
DLRC’s expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long-term commitment to projects.
We are looking to expand our Regulatory Affairs team and are currently looking for an experienced Regulatory Consultant to join us on a one-year fixed contract or a permanent basis.
This position can be worked on hybrid basis or from our offices in Letchworth, UK.

REQUIRED EXPERIENCE:

· Educated to minimum BSc level within Life Sciences or Pharmacy.
· Previous experience working within Regulatory Affairs
· Previous experience of developing and maintaining global labelling content
· Good work ethic & strategic mindset
· Experience working with EU requirements, US highly advantageous
· Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities
· Analyse and understand current and future regulatory environment and its impact on assigned projects and apply to the business environment.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

THE ROLE

The Regulatory Consultant will be responsible for managing a portfolio of projects for a number of clients. This will include labelling management but may also encompass projects in clinical development, at MAA filing stage and post approval lifecycle management.

RESPONSIBILITIES:

· Lead and support regulatory projects on behalf of the client including liaising and negotiation with regulatory authorities
· Manage and support regulatory procedures at both the national and EU level
· Manage and support US projects as required
· Prepare and oversee the development and maintenance of core data sheets, and core patient product information as well as local product labels throughout the product lifecycle
· Ensuring regulatory compliance as required
· Prepare regulatory submissions and agency interactions
· Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
· Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business
· Prepare and manage regulatory submissions and agency interactions
· Develop regulatory plans to meet project and client goals.
Regulatory Affairs Consultant at DLRC
Letchworth, England, United Kingdom - Full Time
Skills Needed
Life Sciences, Regulatory Affairs
Qualification
BSc
Regulatory Affairs Associate at Career Connections Canada Inc
Mississauga, ON, Canada - Full Time
Skills Needed
Computer Skills, Adobe Acrobat, Regulatory Affairs, Communication Skills, Chemistry, Analytical Skills, Dental Care, It, Harmonization
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at PRESTIGE BIOPHARMA LIMITED
Singapore, , Singapore - Full Time
Skills Needed
Chemistry, Regulatory Affairs, English, Clinical Trials
Specialization
Chemistry
Qualification
Graduate
Regulatory Affairs Specialist at OrthoPediatrics
Warsaw, Indiana, United States - Full Time
Skills Needed
Regulatory Strategy, Technical Writing, Communication Skills, Project Management, Medical Device Regulations, Verification And Validation, Database Management, Labeling Compliance, Problem Solving, Team Collaboration, Product Development, Regulatory Submissions, Change Assessment, Testing Requirements, Documentation Review, Regulatory Procedures
Specialization
Candidates should have a fundamental understanding of medical device terminology and regulations, along with excellent technical writing and communication skills. A bachelor's degree and a minimum of 2 years of experience in regulatory affairs for medical devices are preferred.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Kerecis LLC
Minneapolis, Minnesota, United States - Full Time
Skills Needed
Regulatory Affairs, Fda Applications, Regulatory Strategies, Document Drafting, Risk Assessment, Analytical Skills, Problem Solving, Communication Skills, Team Collaboration, Medical Device Development, Iso Requirements, Product Development, Testing Protocols, Attention To Detail, Microsoft Office, Creative Thinking
Specialization
Candidates should have a bachelor's degree in Engineering or a related field and at least 5 years of experience in the Medical Device field. Experience in regulatory roles supporting pre-market product development is also required.
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Regulatory Affairs, Adobe Acrobat, Analytical Skills, Computer Skills, Dental Care, Communication Skills, It, Harmonization, Chemistry
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Specialist at CooperSurgical
Remote, Scotland, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Specialization
Relevant Field
Qualification
MSc
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at NDR Medical Technology Pte Ltd
Singapore 139953, , Singapore - Full Time
Skills Needed
Interpersonal Skills, Device Development, Presentation Skills, Timelines
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Government Affairs Lead, Gulf at Amgen
Dubai, , United Arab Emirates - Full Time
Skills Needed
External Relationships, Communication Skills, Internal Customers, Strategic Counsel
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr Manager Regulatory Affairs at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Samd Regulations, Fda Guidance, Iso Standards, Technical Documentation, Team Management, Digital Health Products, Cybersecurity, Data Privacy, Software Development, Ai/Ml Technologies, Agile Methodologies, Change Management, Product Classification, Regulatory Submissions, Quality Assurance
Specialization
Candidates typically require a Bachelor’s degree and 13+ years of relevant experience in the medical device industry, including 5-8 years of people management experience. A minimum of 5 years of regulatory affairs experience is also required.
Experience Required
Minimum 10 year(s)
Graduate - Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands
London, England, United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Communication, Teamwork, Initiative, Proactivity, Academic Curiosity, Integrity, Transparency, Accountability, Diversity, Inclusivity, Regulatory Strategy, Regulatory Compliance, Life Cycle Maintenance, Health Authority Interactions, Operational Excellence
Specialization
Candidates should have a degree in relevant fields such as Pharmacy, Chemical Engineering, or Biology. The program is open to students based in the UK who complete their undergraduate degree between 2024 and 2026.
Regulatory Affairs Specialist at OrganOx
Oxford, England, United Kingdom - Full Time
Skills Needed
Management System, Regulatory Affairs, Regulatory Submissions, Organization Skills, Documentation, Microsoft Word, Excel, Maintenance
Qualification
Graduate
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Adobe Acrobat, It, Dental Care, Communication Skills, Computer Skills, Analytical Skills, Chemistry, Harmonization, Regulatory Affairs
Qualification
BSc
Experience Required
Minimum 5 year(s)
Public Affairs Community Lead at Roche
Welwyn, England, United Kingdom - Full Time
Skills Needed
Government Officials, Public Affairs
Qualification
Graduate
Regulatory Affairs Specialist at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Medical Device, Software Development, Technical Documentation, Cross Functional Collaboration, Risk Assessment, Fda Regulations, Iso Standards, Agile Methodologies, Digital Health, Ai Technologies, Mobile Development, Cloud Based Solutions, Change Assessment, Validation Activities, Product Labeling
Specialization
Candidates should have experience in medical device design and development processes, along with knowledge of relevant regulations and standards. Excellent writing and communication skills are essential, as well as experience in a cross-functional environment.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at Hyperfine
Guilford, Connecticut, USA - Full Time
Skills Needed
Regulatory Affairs, Regulatory Submissions, Emerging Technologies, Medical Imaging, Regulations, Outlook, Nomenclature, Communication Skills, Excel
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Associate at Katalyst Healthcares Life Sciences
Columbia, MD 20588, USA - Full Time
Skills Needed
Regulatory Affairs, Medical Devices, Manufacturing
Specialization
Chemical
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialist at Heidi Health
Melbourne, Victoria, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist at Sysmex UK
Milton Keynes, England, United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Public Affairs Manager at Lalamove
Manila, Metro Manila, Philippines - Full Time
Skills Needed
Public Policy, Government Relations, Stakeholder Engagement, Research, Strategic Communications, Partnership Development, Regulatory Compliance, Esg Strategies
Specialization
Candidates should have a degree or master's degree in public policy and experience with local and national government agencies. They must also have experience in strategic communications and partnership plans.
Experience Required
Minimum 5 year(s)