Senior Regulatory Affairs Specialist

1 week ago


Durham, North Carolina, United States Asensus Surgical US, Inc. Full time
Senior Regulatory Affairs Specialist sought by Asensus Surgical US, Inc. in Durham, NC who will be responsible for developing global regulatory strategies for surgical robotic medical devices. Author, prepare and submit FDA premarket 510(k) submissions, CE marking and international product registrations. Prepare regulatory assessments and provide regulatory approval for product changes. Engage FDA regulators to discuss pending and new submissions and regulatory requirements.

Lead the development of on-product labeling; advise and approve advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals.

Prepare regulatory documentation for international product registration, including EU technical files and Certifications to Foreign Governments and Certificates for Export.

Interpret regulations and provide regulatory guidance to global teams. Bachelor's degree in engineering, scientific discipline, regulatory affairs or related field. (U.S. or foreign equivalent).

2 years' experience in a Regulatory Affairs role for a medical device company working with US FDA regulations and Quality System regulations and Medical Device Regulation (EU) 2017/745.

Employer performs drug testing/screening, reference and background checks, education verification and employment verification. Resumes to
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