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Sr. Regulatory Affairs Specialist - Medical Device (Science & Biotech)
Durham, NC 27710
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Oct 10, 2019
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Job Description

Senior Regulatory Specialist is responsible for coordinating the registrations of products in US and/or international markets.

Plan, compile, prepare, and submit applications (510(k), PMA, Technical Documentation, etc.) to register new, and re-register existing, company products with foreign regulatory agencies.
Communicate with FDA and other regulatory bodies regarding submissions.
Review and approve changes for design, manufacturing and labeling changes to ensure compliance with FDA and international government regulations.
Own device labeling and ensure compliance with FDA and international requirements and design controls.
Facilitate/perform all administrative and technical phases of regulatory submission, including coordination of legalization activities of registration documents, scanning, formatting, compiling, quality control and proof-reading.
Work on project teams to develop regulatory strategies, test protocols and reports, labeling, risk management, design control and other documentation to ensure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
Working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.
Coordinate sales and supply chain efforts to ensure compliance with registration and distribution requirements; Work effectively in a team environment, facilitating communication and monitoring progress against the project plan.
Develop product labeling and packaging and coordinate label improvement opportunities with Marketing, packaging development and business development

BS/BA, in regulatory affairs, engineering, life sciences or related discipline
Minimum 5 years of experience with at least 3 years of relevant US and/or international medical product registrations experience
Must possess highly-effective written and verbal communication skills.
Must be detail oriented and possess considerable organization skills.
Working knowledge of design controls, risk management, CGMPs, etc.
Class III PMA medical device, Medical Device Regulation (EU), Canadian Medical Device Regulation; direct work experience in drug, biologics or another regulated industry or like discipline is desirable.