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Regulatory Affairs Specialist at Viscot MedicalLLC
East Hanover, NJ 07936, USA - Full Time
Skills Needed
Iso, Excel, Stem, Medical Devices
Specialization
Stem and a minimum of 2 years of related experience
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Flora Food Group
Wageningen, Gelderland, Netherlands - Full Time
Skills Needed
Regulatory Affairs, Project Management, Analytical Skills, Communication Skills, Technology Innovation, Compliance, Knowledge Management, Collaboration, Ai, Data Science, Food Science, Nutritional Claims, Market Insights, Training, Continuous Improvement, Digital Literacy
Specialization
Candidates should have a bachelor's or master's degree in chemistry, Food Science, or a related field, along with a minimum of three years of experience in Regulatory Affairs. Strong analytical skills, project management experience, and fluency in English are essential.
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 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 Katalyst Healthcares Life Sciences
Boulder, CO 80301, USA - Full Time
Skills Needed
Excel, Pharmaceutical Industry, Communication Skills, Outlook, Interpersonal Skills, Computer Skills, Regulatory Affairs, Adobe Acrobat
Specialization
Pharmaceutical industry
Qualification
Graduate
Experience Required
Minimum 3 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 AbbVie
Montréal, QC, Canada - Full Time
Skills Needed
Medical Devices, Biology, Biochemistry, Biologics, Small Molecules, Pharmaceutical Industry, Regulations, Microbiology, Regulatory Affairs, Regulatory Submissions, Disabilities, Chemistry, English, Life Sciences, Toxicology, Filing, Pharmacology, Working Environment
Specialization
Biochemistry biology microbiology chemistry
Qualification
MSc
Experience Required
Minimum 1 year(s)
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 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)
Academic Affairs Coordinator at Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States - Full Time
Skills Needed
Administrative Support, Interpersonal Skills, Organization Skills, Communication Skills, Detail Oriented, Time Management, Problem Solving, Confidentiality, Computer Literacy, Ms Office Proficiency, Coordination Skills, Adaptability, Independent Work, High Volume Management, Faculty Support, Recruitment Guidelines
Specialization
A high school diploma is required, with a bachelor's degree preferred. Candidates should have previous administrative experience in an academic environment, ideally with at least two years of coordination experience.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, 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 Abbott
Macquarie Park, New South Wales, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 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)
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 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 Associate at Viatris
Sydney, New South Wales, Australia - Full Time
Skills Needed
Chemistry, Regulatory Guidelines, Communication Skills, Regulatory Affairs
Specialization
Pharmacy science or chemistry
Qualification
Graduate
Experience Required
Minimum 2 year(s)
AGM-GRA (Regulatory Affairs) at Kashiv BioSciences, LLC
, gujarat, India - Full Time
Skills Needed
Exposure In Emerging Markets, Regulated Markets, Regulatory Guidance, Dossier Preparation, Biosimilars, Nces
Specialization
Candidates should have a Master's degree in biotechnology or related fields with 12-15 years of experience. Skills in regulatory guidance and dossier preparation for biosimilars and NCEs are essential.
Experience Required
Minimum 10 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)
Regulatory Affairs Specialist at Superior Skilled Trades
Pittsburgh, PA 15205, USA - Full Time
Skills Needed
Chemistry, Product Safety, Biology, Computer Skills, Communication Skills, Microsoft Excel, Databases
Specialization
Chemistry biology or a related science field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Consultant at DLRC
Letchworth, England, United Kingdom - Full Time
Skills Needed
Life Sciences, Regulatory Affairs
Qualification
BSc
Regulatory Affairs Specialist at Viscot MedicalLLC
East Hanover, NJ 07936, USA -
Full Time

Start Date

Immediate

Expiry Date

28 Nov, 25

Salary

79000.0

Posted On

28 Aug, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Iso, Excel, Stem, Medical Devices

Industry

Pharmaceuticals

Description

JOB SUMMARY

Viscot Medical, a global medical device company, is seeking an experienced Regulatory Affairs Specialist. Reporting to the Director of Quality, the Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements.

QUALIFICATIONS

  • Bachelor’s degree in STEM AND a minimum of 2 years of related experience.
  • Working knowledge of ISO 13485 or ISO 9001
  • Working knowledge of 21 CFR 800 for Medical Devices and EU MDR
  • Experience with pre- and post-market medical device submissions support such as 510(k), IDE., PMA preferred
  • RAPS certification: RCC or RAC is preferred
  • ASQ certification: CQE or CQA is preferred
  • Proficiency in MS Word and Excel
  • Analytical thinking with clear and effective verbal and written communication skill
  • Ability to work collaboratively in a fast-paced environment while managing multiple priorities

How To Apply:

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

Responsibilities
  • Respond to internal and external requests for compliance and regulatory matters
  • Ensure compliance of QMS as Document Control and CAPA manager
  • Work with Quality management, product development, and operations to assist with interpretation and compliance of applicable standards (e.g. ISO, FDA, EU MDR)
  • Provide country specific regulatory support
  • Liaise with our Authorized Representatives in various global regions
  • Knowledge of Quality processes to support audit functions
  • Assist with shipping authorization documentation for assigned geographies
  • Ability to perform as team member for multiple concurrent tasks with accuracy
  • Provide support to Quality Department for change or improvement initiatives
  • Analyze and present data to functional managers
  • Other duties as assigned
Regulatory Affairs Specialist at Viscot MedicalLLC
East Hanover, NJ 07936, USA - Full Time
Skills Needed
Iso, Excel, Stem, Medical Devices
Specialization
Stem and a minimum of 2 years of related experience
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Flora Food Group
Wageningen, Gelderland, Netherlands - Full Time
Skills Needed
Regulatory Affairs, Project Management, Analytical Skills, Communication Skills, Technology Innovation, Compliance, Knowledge Management, Collaboration, Ai, Data Science, Food Science, Nutritional Claims, Market Insights, Training, Continuous Improvement, Digital Literacy
Specialization
Candidates should have a bachelor's or master's degree in chemistry, Food Science, or a related field, along with a minimum of three years of experience in Regulatory Affairs. Strong analytical skills, project management experience, and fluency in English are essential.
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 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 Katalyst Healthcares Life Sciences
Boulder, CO 80301, USA - Full Time
Skills Needed
Excel, Pharmaceutical Industry, Communication Skills, Outlook, Interpersonal Skills, Computer Skills, Regulatory Affairs, Adobe Acrobat
Specialization
Pharmaceutical industry
Qualification
Graduate
Experience Required
Minimum 3 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 AbbVie
Montréal, QC, Canada - Full Time
Skills Needed
Medical Devices, Biology, Biochemistry, Biologics, Small Molecules, Pharmaceutical Industry, Regulations, Microbiology, Regulatory Affairs, Regulatory Submissions, Disabilities, Chemistry, English, Life Sciences, Toxicology, Filing, Pharmacology, Working Environment
Specialization
Biochemistry biology microbiology chemistry
Qualification
MSc
Experience Required
Minimum 1 year(s)
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 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)
Academic Affairs Coordinator at Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States - Full Time
Skills Needed
Administrative Support, Interpersonal Skills, Organization Skills, Communication Skills, Detail Oriented, Time Management, Problem Solving, Confidentiality, Computer Literacy, Ms Office Proficiency, Coordination Skills, Adaptability, Independent Work, High Volume Management, Faculty Support, Recruitment Guidelines
Specialization
A high school diploma is required, with a bachelor's degree preferred. Candidates should have previous administrative experience in an academic environment, ideally with at least two years of coordination experience.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, 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 Abbott
Macquarie Park, New South Wales, Australia - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 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)
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 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 Associate at Viatris
Sydney, New South Wales, Australia - Full Time
Skills Needed
Chemistry, Regulatory Guidelines, Communication Skills, Regulatory Affairs
Specialization
Pharmacy science or chemistry
Qualification
Graduate
Experience Required
Minimum 2 year(s)
AGM-GRA (Regulatory Affairs) at Kashiv BioSciences, LLC
, gujarat, India - Full Time
Skills Needed
Exposure In Emerging Markets, Regulated Markets, Regulatory Guidance, Dossier Preparation, Biosimilars, Nces
Specialization
Candidates should have a Master's degree in biotechnology or related fields with 12-15 years of experience. Skills in regulatory guidance and dossier preparation for biosimilars and NCEs are essential.
Experience Required
Minimum 10 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)
Regulatory Affairs Specialist at Superior Skilled Trades
Pittsburgh, PA 15205, USA - Full Time
Skills Needed
Chemistry, Product Safety, Biology, Computer Skills, Communication Skills, Microsoft Excel, Databases
Specialization
Chemistry biology or a related science field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Consultant at DLRC
Letchworth, England, United Kingdom - Full Time
Skills Needed
Life Sciences, Regulatory Affairs
Qualification
BSc