Sr. Regulatory Affairs Specialist at GForce Life Sciences in Los Angeles, CA

GForce Life Sciences
September 18, 2020
Los Angeles, CA


Apply You will be redirected to GForce Life Sciences's preferred application process.

(REMOTE) Consultant, Sr. Regulatory Affairs Specialist, Medical Device

GForce Life Sciences is a consulting firm that provides leadership and teams to some of the world’s leading pharmaceuticals, medical devices, & diagnostic manufacturers, middle-market clientele, and recently funded startups. Headquartered in Chicago with a nationwide presence, GForce has successfully completed countless engagements for clients ranging from Fortune 500 to startups. Duties / Expectations of Role Support product development teams on regulatory issues, including review of documentation Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filing justifications, Technical File creation/updates, Canadian License Applications. Identify and convey requirements from applicable standards and guidance documents to project teams Be the subject matter expert for the company in complying with FDA guidance documents regarding cybersecurity Provide leadership on documentation issues and mentor teams on requirements Continuous improvement of the submission process in accordance with the client Product Development Process Work directly with regulatory agencies on regulatory issues and submissions Support international regulatory efforts as needed Perform other duties as required Requirements 8 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science) 6 years of experience in submissions and technical documentation for medical devices (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science plus 3 years) Experience with new product development projects for complex products Experience with software controlled and standalone software medical devices including cybersecurity. Skills Ability to work in a fast paced environment and handle multiple projects simultaneously Ability to create 510(k) submissions, memos-to-file, and technical documentation for complex new products and product changes Strong understanding of design controls with experience in verification and validation methods and documentation Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc. Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions Ability to digest and convey information to project teams from regulators including regulations, guidance documents and standards Ability to review and provide critical feedback on design documentation Ability to learn internal procedures and processes and implement on project teams Good interpersonal skills and able to work well with cross-functional teams Good project management skill


B.S. or higher in Engineering or in a Science field or equivalent related experience Term & Start Remote (client based in San Jose, CA area) ASAP 12-18 month contract
Job Expires: 2020-10-19
Apply You will be redirected to GForce Life Sciences's preferred application process.

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