- Title: Regulatory Affairs Associate
- Code: RCI-17040
- Location: Santa Clara California (CA) 95054
- Posted Date: 09/14/2021
- Duration: 6 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Open for non-local candidates who are ready to relocate at their own expense from day 1
Updates From manager
- College grads with academic exp will work
- Would work on supporting International submission, registration and renewals
- Support Quality system for regulatory affairs
- Any exposure to submission, registration and product submissions
- 1 year exp in regulatory affairs
- This is an onsite role
- Technical background
- Bachelor’s degree in engineering or science background
- Supporting international submission work
- Won’t be generating content or involved in new product
- Client will provide training in quality systems
Years Experience: 1+ years experience in a medical device or similarly regulated industry
Skills: Ability to schedule and organize multiple projects
Education: BS Engineering or Scientific
- Manager regulatory submissions ot 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.
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 Vascular 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.