What are the responsibilities and job description for the Senior Manager, Global Regulatory Affairs position at RIVERPOINT MEDICAL LLC?
Riverpoint Medical in Northeast Portland is hiring for Senior Manager, Global Regulatory Affairs – EUMED & Clinical Programs. We are hiring for a hybrid or fully remote position. At Riverpoint you will be part of the process to build superior solutions and rapidly innovate high quality medical devices to improve patient outcomes. We specialize in the design and manufacturing of premium medical devices in the Medical, Dental and Veterinary markets. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, cardiovascular textiles, surgical lighting, and special needle technologies.
The Senior Manager will lead regulatory strategies and execution for EU Medical Device Regulation (EU MDR) submissions and post-market clinical follow-up (PMCF) activities. This role ensures compliance with evolving European regulatory requirements while supporting the lifecycle of Riverpoint’s medical devices through clinical data generation and regulatory documentation.
Duties and Responsibilities:
- Lead the preparation, review, and submission of technical documentation for CE marking under EU MDR.
- Serve as the primary liaison with Notified Bodies and EU regulatory authorities.
- Oversee the development and execution of PMCF plans and reports in alignment with EU MDR requirements.
- Ensure clinical data collection supports safety and performance claims for existing products.
- Design and monitor post-market studies.
- Manage and mentor a team of regulatory and clinical professionals.
- Develop and implement regulatory strategies to support product development and market expansion.
- Monitor regulatory trends and proactively adapt submission strategies.
- Ensure all documentation meets EU MDR, ISO 14155, and other applicable standards.
- Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions to comply with the state of the art.
- Maintain up-to-date regulatory files and records in accordance with internal SOPs and external regulations.
Qualifications:
- Minimum 5-15 years knowledge and experience in Regulatory Affairs and/or Clinical Affairs in the manufacture and distribution of sterile, disposable medical devices
- Experience with MDR Clinical Evaluation Reports, Post Market Clinical Follow-up, Post Market Surveillance, Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP), and Clinical Evaluations.
- Certified ISO13485 auditor or equivalent job training.
- Ability to create technical dossiers for customer regulatory submissions, experience with 510(k), MDR, Canada, Australia, or Brazil regulatory submissions.
- Experience with FDA QSR (21 CFR 820), MDR, and MDSAP requirements. Ability to interpret regulations, guidance and correctly apply them as appropriate in product development.
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
