regulatory affairs associate Jobs in westborough, ma

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Regulatory Affairs CMC Officer

Danaher Corporation

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Marlborough, Massachusetts, USA

Full-time

Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and the
Posted 6 days ago | Updated 3 hours ago

CMC Regulatory Affairs Manager

TechSpace Solutions Inc.

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Remote

Third Party, Contract

Job Title : CMC Regulatory Affairs Manager Location : Remote Duration : 12 Months Responsibilities: Leading project teams, ensuring maintenance of team records and process-related documentation i.e., process maps, job aids, project trackers, checklists, etc.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for
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Posted 3 days ago | Updated 3 days ago

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

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Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities- -Authoring US FDA 510(k) submission using eSTAR submission tool.
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Posted 4 days ago

Principal Regulatory Affairs Specialist (Remote)

Medtronic

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Remote or Los Angeles, California, USA

Full-time

Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's w
Posted 6 days ago | Updated 6 hours ago

Regulatory/ Pharmacovigilance Associate (REMOTE)

NetSource, Inc.

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Remote

Contract

Please note that this is a 1 year contract position. HIGHLIGHTED SKILLS: - Role can be 100% REMOTE - May travel for a possible mandatory meeting onsite (Raritan, NJ) for 1-2 days, not very often at all - Bachelors Degree required - Pharmacovigilance experience needed - Must be flexible / adaptive - Must be able to problem solve, and know when to ask for help - Working within the Global Environment / Global Teams - Regulatory Affairs experience - MAIN ASPECT OF ROLE: Support Aggregate Tracking p