Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) Bachelor?s degree in a scientific discipline
2) RAC certification
3) Minimum 5+ years experience in Regulatory Affairs in FDA regulated medical device environment
4) Successful with FDA and International submissions (i.e.510K, PMA, CE Marketing?s, IDE, etc.) and technical writing
Job Description
Print Job Description
Partial Job Description 1) Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines 2) Ensure compliance with all US, EU and SO international requirement, corporate policies and procedures regarding submissions for market approval of medical devices/combination products 3) Participate in product development teams to ensure US and other international regulatory requirements are incorporated as part of the development process 4) Deal with author submissions and other regulatory documents to obtain approval to bring new or modified products to market 5) Assist in post market submissions (progress reports, annual reports etc.) 6) Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers 7) Address and advice teams on appropriate pathways to market 8) Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals and other issues 9) Establish and maintain regulatory information systems both electronically and hard copy 10) Interpret existing and/or new regulatory requirements as they relate to company products and procedures 11) Review and approve ECN's, OCN's, etc. while considering both US and international regulatory requirements 12) Prepare and update US product listings 13) Communicate any FDA correspondence on submissions to the appropriate team(s) and RA management 14) Participate in BPX project teams 15) Take responsibility of labeling, marketing, product transfer and literature review pre and post market, technical file and design dossier construction 16) Assist the RA Manager and others with the development, implementation and maintenance of regulatory SOP's 17) Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of company business process excellence initiative 18) Mentor to other members of the Clinical Research team
