Biolink 360

Our client is an industry leading Regulatory and Quality consulting company that has consistent year over year growth and is on a major upswing with Design Assurance hiring. They work with startups to fortune 500 device companies, providing a variety of client projects. These are full-time, permanent hire, remote-based positions.

This has been the regular business model for many years, with full integration into client teams to meet project deliverables. Key highlights: - Women-owned business, established for 10 years with owners actively involved. - Expert team members with opportunities to work on new technologies, projects, and clients.

- High employee satisfaction, with over 30% of hires this year from Associate referrals. - Minimal travel to client sites required. - Unlimited time off and a focus on work/life balance.

The person filling this role will work with a CMO on devices. Skillsets: Must have design assurance/design control knowledge, DHF development experience (having built a DHF from scratch), familiarity with device products, risk management experience, V&V planning/reporting (including sampling), familiarity with submissions, sterilization, biocompatibility, paper-based DHF, and design transfer. Responsibilities: - Provide design assurance support to review/create a DHF for clients.

- Develop Design Control SOPs for products. Major deliverables include: Design Inputs, uFMEA, dFMEA, Risk Management Plan, Hazards Analysis, Design Verification Plan, Design Verification Report (including IFU & Labeling verification), Traceability Matrix, Design and Development Plan. - Mentor and guide client teams on industry standard practices for product development, particularly on the device side.

- Work within client SOPs while advising on QMS updates to standardize design control best practices including risk management. Other: - International client / Eastern Time zone preferred. - ISO 13485:2016 and applicable regulatory requirements of US FDA and Europe MDR.

There will be multiple hires of DA professionals with 2-15 years of experience over the next few months, starting in Jan/Feb. Contacts: For further information, please contact: Hiring Organization: Employment Type: Full-time Beginning of Employment: ASAP Medical Device/Pharma Job Location: Remote work from: USA; New Jersey, USA; D.C., USA; Pennsylvania, USA; #J-18808-Ljbffr