Riverpoint Medical in Northeast Portland is hiring for Regulatory Affairs Associate II. We are hiring for a fully onsite or remote position. At Riverpoint you will be part of the process that brings great technology to 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.

As a full time, Regulatory Affairs Associate II you will:

• Support, prepare, and file regulatory submissions for approval, FDA 510(k), EU MDR/CE, and other international markets.
• Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International.
• Prepare and file regulatory notices and notifications for post market surveillance and vigilance.
• Collaborate with customers to create and maintain technical documentation for regulatory submissions.
• Generate annual medical device management review reports.
• 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.
• Review and approve Clinical Evaluation, Post-market Surveillance, and Post Market Clinical Follow-up reports.
• Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.
• Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy.

QUALIFICATIONS FOR THIS GREAT OPPORTUNITY INCLUDE:

• Minimum 3-10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of sterile, disposable medical devices
• 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.
• Experience with Pre-Market and Post-Market regulatory support, including ISO10993, ISO14971, EN62366, ISO20417, ISO15223, Post Market Clinical Follow-up, Post Market Surveillance, Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP), and Clinical Evaluations.
• 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.
• Customer centric attitude, and experience with customer service is preferred.
  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. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus!
  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.

Please refer the Job description for details