Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: San Francisco, California
Salary: Negotiable
Start Date: asap
Reference: HQ00054401_1491927131
Contact Name: Pavlina Bullaj
Contact Email:
Job Published: April 11, 2017 17:12

Job Description

Regulatory Affairs Manager


  • Medical Device background
  • San Francisco Bay Area
  • Writing/ preparing & managing medical device submissions such as 510(k)
  • Good working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820


SciPro Global is currently looking for a Regulatory Affairs Manager for one of my key clients in the San Francisco Bay area. We are seeking a hands-on Regulatory Affairs Manager to supports the Company's regulatory activities across a variety of programs - the Regulatory Affairs Manager should have sufficient experience in regulatory submissions such as 510(k), PMA, IDE, De Novo as well as compliance to provide direction and guidance to R&D, manufacturing, marketing/sales to changing regulatory requirements and standards.

  • The ideal candidate would have had previous medical device experience.
  • Write, prepare, and manage regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, Health Canada License, etc.)
  • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
  • Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820
  • Experience in developing, writing and submitting successful IDE/510(k)/PMA/De Novo submissions
  • Bachelor's degree in a scientific discipline; advanced degree and RAC preferred
  • Five or more years' experience in regulatory affairs with direct project and personnel management responsibilities
  • Experience in software development and software quality as it relates to regulatory submissions a plus.

This is a great opportunity for someone to join a fast growing team and dynamic team & taking the next step in your career.

If this is something you could be interested in, please apply below or alternatively send me an email with to with your availability and contact details.

I look forward to speaking to you!