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Regulatory Affairs Manager
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Regulatory Affairs Manager
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Regulatory Affairs Manager
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Regulatory Affairs Manager
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3M Group Maplewood, United StatesRegulatory Affairs Manager (Maplewood, MN) page is loaded · Regulatory Affairs Manager (Maplewood, MN) · Apply · remote type · Hybrid · locations · US, Minnesota, Maplewood · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R · Job Descrip ...
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Manager Regulatory Affairs
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Manager Regulatory Affairs
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Regulatory Affairs Manager
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Sr Manager, Regulatory Affairs
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Manager, Medical Affairs
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Manager, Regulatory Affairs
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Manager, Medical Affairs
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Regulatory Affairs Manager
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Boston Scientific Arden Hills, United States Regular, Full timeRecruiter: Spencer Gregory Hale · Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC · Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulat ...
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Regulatory Affairs Manager
1 week ago
3M Saint Paul, MN, United StatesJob Description:Regulatory Affairs ManagerCollaborate with Innovative 3Mers Around the WorldChoosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and ...
Regulatory Affairs Manager - Hopkins, United States - Custom Search
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Description
Our mid sized medical device client is adding a Manager Regulatory Affairs to the team.The Manager ensures compliance with applicable laws and regulations in the development, manufacturing, and marketing of products and its subsidiaries' products, and uses this knowledge to support pre-market and post-market activities and will work closely with Quality Assurance, Clinical Affairs, Sales and Marketing, Engineering, and Manufacturing for compliance to regulations.
Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.Your role with the company:
Manage the daily operations of the Regulatory Affairs, including:
Management of 3 Regulatory Affairs Specialists
Oversee and prepare domestic and international regulatory submissions.
Prepare and review 510(k) and PMAs and PMA supplements for new and current products.
Provide guidance and oversight to team members related to regulatory compliance.
Provide regulatory input to companies design teams for the development of new products or procedures.
Support inspections by FDA, notified body, and other regulatory agencies.
Desired Profile:
Bachelor's Degree with at least 5-8 years of related Regulatory experience, mostly in medical devices.
1+ years' experience in a Regulatory Affairs management role.
Extensive knowledge of global medical device regulations and standards, such as, but not limited to FDA, MDD, EU MDR, Health Canada, Australia, Japan etc.
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