Berkeley, United States
over 1 year ago
The open position is within the Regulatory Affairs group which is part of the Quality Management team for Molecular products located in Berkeley, CA. The successful candidate would be responsible for representing regulatory affairs on project core teams, submitting EU technical files and renewals, preparing and participating in meetings with the FDA, submitting 510(k) and PMA files as well as any updates for in-vitro diagnostics and medical devices platform. The successful candidate will report in to the position site Regulatory Head within the business unit.
- Provide regulatory guidance for and participate in new product development for IVD products including diagnostic assays, instruments and software
- Drive regulatory submissions, regulatory agency communications and other tasks for compliance purposes including MDSAP.
- Work with the RA team in the writing and filing of appropriate FDA submissions
- Review and approve project DHF documentation for compliance with EU and FDA regulations.
- Supports the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
- Support updating IVD products to meet the IVD Regulation.
Required Knowledge/Skills, Education, and Experience
- Minimum BA/BS in a scientific discipline
- Regulatory Affairs representative on assay, hardware and software product core teams
- Highly developed writing and interpersonal skills
- 10% travel required
- Ability to interact and communicate efficiently with global regulatory agencies, work on multiple teams and work independently
- Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)
Preferred Knowledge/Skills, Education, and Experience
- BS degree in Engineering, Molecular Biology or Biochemistry preferred
- Prior experience in in-vitro diagnostics highly preferred
- Prior experience with EU regulations for instruments and software preferred
- Knowledge of IVDD Harmonized Standards preferred
- RAPS Regulatory Affairs Certification preferred
Minimum of 3 years experience