Regulatory Affairs Assoc III - Biocompatability Toxicology

RIVERPOINT MEDICAL LLC • Portland, OR

5d • Onsite

About The Position

Riverpoint Medical in Portland, Oregon is looking to hire a Regulatory Affairs Associate III – Biocompatibility and Toxicology. At Riverpoint, you will be part of the process that brings great technology to the Medical, Dental, and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.

Requirements

• 9+ years biocompatibility/regulatory affairs experience including increasing responsibilities and ownership of biocompatibility expertise over time or MS in biocompatibility topics plus 4+ years biocompatibility/regulatory affairs experience
• Recognized technical and regulatory authority
• Ability to create technical documentation for customer regulatory submissions.
• The ability to interpret regulations, guidance and correctly apply them as appropriate in product development.
• Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
• Ability to review detailed scientific information and assess whether technical justifications are presented clearly, and conclusions are adequately supported by data.
• Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.

Nice To Haves

• Customer Centric attitude, and experience with customer service is preferred

Responsibilities

• Develop and execute biocompatibility evaluation plans (BEPs) in alignment with ISO 10993 and other applicable standards
• Conduct risk assessments related to biological safety of materials and finished products
• Coordinate and oversee in vitro and in vivo biocompatibility testing with external laboratories or internal teams
• Review and interpret toxicological and biological data to determine product safety
• Prepare and maintain biocompatibility reports (BERs) for regulatory submissions (FDA, EMA, etc.)
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical, Manufacturing)
• Support material selection and change control with respect to biological safety
• Provide guidance on regulatory requirements and standards (ISO 10993, USP, FDA guidance)
• Investigate and assess product complaints or adverse events related to biological interactions
• Stay current with evolving regulations, standards, and scientific advancements
• Lead complex US and international regulatory submissions and strategies
• Serve as internal regulatory authority across multiple regulatory disciplines
• Approve CEPs, risk-based regulatory decisions, and change assessments
• Provide regulatory guidance to R&D, Quality, Manufacturing, and Commercial teams
• Mentor junior regulatory staff and provide technical review oversight
• Represent Regulatory Affairs in audits, inspections, and high-risk discussions
• Drive continuous improvement of regulatory processes and standards

Benefits

• Medical
• Dental
• Vision
• Life and Accidental Death Insurance
• 401(k) with company match and immediate vesting
• Paid Time Off
• 9 company paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior