- Title: Regulatory Affairs Associate
- Code: RCI-11354
- Location: Santa Clara California (CA) 95054
- Posted Date: 02/22/2021
- Duration: 12 Months
- Name:Mangesh Kanade
- Email: email@example.com
- Phone: 908-704-8843 ✖ 260
100% Onsite position The Regulatory Affairs Operations (Reg Ops) organization is a divisional function responsible for providing Quality System and Compliance support to the Regulatory Affairs key stakeholders, and to the Vascular Business Unit.
- This support includes, but is not limited to, establishing processes and procedures for the Product Approval Key Process to ensure conformance to regulatory requirements, innovative solutions to enable release of approved product to the market, CAPA investigations and definition of resolution plans to prevent recurrence/occurrence, keeping a pulse on global Emerging Issues and assessing impact to the Quality System or registrations, regulatory document management (issuance, archival, etc.), and Audit Support (external, internal, corporate).
- Business impact and benefit to Client are exhibited by ensuring WW regulatory and addendum labeling requirements are robust in the quality system; by increasing our compliance portfolio; by supporting Quality Systems roll out to the RA organization; and by strengthening conformance to regulatory requirements.
- 1+ years’ experience in a medical device or similarly regulated industry
- Ability to schedule and organize multiple projects
- BS Engineering or Scientific
- Manager regulatory submissions to ensure timely regulatory approval of medical devices.
- Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
- Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines.