- Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.
- Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations. Trains to and executes document management within local Product Lifecycle Management system and other electronic documentation systems as applicable.
- Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.
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Regulatory Affairs Specialist
2 weeks ago
Smith+Nephew Andover, United States Full timeLife Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. · This role will be focused on the continuously growing Sports Medicine franchise at Smith + Nephew that serves our patients and customers to live Life Unlimited. This position ...
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Regulatory Affairs Specialist
4 days ago
Sunrise Systems Inc Andover, United StatesJob Title: Regulatory Affairs Specialist - Labeling - Junior · Job ID: · Location: Andover, MA · Duration: 12 Months contract on W2 · Description: · Role Overview · Include specific internal and external relationships, product focus, regulatory requirements, physica ...
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Regulatory Affairs Specialist
2 weeks ago
JobsRUs Andover, United StatesSeeking to hire a Regulatory Affairs Specialist for my client in Andover, MA 1810 · Benefits and weekly pay available · 38.46 per hour · Hybrid · Role Overview · include specific internal · and external · relationships, product · focus, regulatory · requirements, physica ...
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Regulatory Affairs Specialist
2 weeks ago
ProKatchers LLC Andover, United StatesJob Summary: · include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. · Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation i ...
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Regulatory Affairs Labeling Specialist
2 weeks ago
Compunnel, Inc. Andover, United StatesJob Description · Job Description · Description:Laptop will not be issued. Operates complex equipment and analytical tools, processes, state of the art 12'' silicon wafers in a clean room environment, which requires appropriate gowning. Technicians are owned in a gore suit that c ...
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Regulatory Affairs Specialist
2 weeks ago
JobsRUs Andover, United StatesJob Description · Job DescriptionSeeking to hire a Regulatory Affairs Specialist for my client in Andover, MA 1810 · Benefits and weekly pay available · 38.46 per hour · Hybrid · Role Overview · include specific internal · and external · relationships, product · focus, regulator ...
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Regulatory Affairs Specialist
2 weeks ago
Integration International Inc. Andover, United StatesDescription: · Role Overview - · Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. · Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulato ...
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Regulatory Affairs Specialist
1 week ago
inSync Staffing Andover, United StatesPay rate: $38.46/hr · Hours: Core hours 10-3, flexible start/finish. 40 hours per week total · Location: Andover, MA. Hybrid- Work location address for onsite and hybrid: Mansfield or Andover · Duration: 1 year · Role Overview : · Through coordination/collaboration with direct su ...
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Regulatory Affairs Specialist
2 weeks ago
NESCO Inc Andover, United StatesThrough coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding ...
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Junior Regulatory Affairs Specialist
1 week ago
Randstad North America, Inc. Andover, United StatesA Junior Regulatory Affairs Specialist is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Andover, MA area. This role involves coordinating with a supervisor to ensure regulat Regulatory Affairs, Specialis ...
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Junior Regulatory Affairs Specialist
1 week ago
Randstad USA Andover, United States Freelance, Full timejob summary: · A Junior Regulatory Affairs Specialist is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Andover, MA area. This role involves coordinating with a supervisor to ensure regulatory compliance ...
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Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
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Scientific Affairs Specialist
2 weeks ago
Bruker Billerica, United StatesScientific Affairs Specialist · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Research & Development · Overview · As one of the world's leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all f ...
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Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
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Scientific Affairs Specialist
2 weeks ago
Bruker Billerica, United States· Scientific Affairs Specialist · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Research & Development · Overview · As one of the world's leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields ...
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Regulatory Affairs Specialist
4 weeks ago
Randstad North America, Inc. Cambridge, United StatesAs a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs, Specialis ...
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Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
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TalentBurst Andover, United StatesTitle: Regulatory Affairs Specialist - Labeling - Junior · Location: Andover, MA · Shift: M-F, 8AM to 5pm · Duration: 12+ months · Job Description: · Role Overview - · include specific internal and external relationships, product focus, regulatory requirements, physical demands, ...
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Regulatory affairs specialist
3 weeks ago
Randstad Cambridge, United Statesjob summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...
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External Affairs Specialist
1 week ago
Breathe Pennsylvania Cranberry, United StatesOrganization Overview: Breathe PA helps residents of western Pennsylvania achieve and maintain optimal lung health through education, prevention, and direct services.Responsibilities and Qualifications: The External Affairs Specialist provides support to organization-wide communi ...
Regulatory Affairs Specialist - Andover, United States - Randstad
Description
Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body. Maintains databases as required. Supports regulatory compliance projects as assigned.
Responsibilities: