Regulatory Affairs Associate

RIVERPOINT MEDICAL LLC•Portland, OR

5d•Onsite

About The Position

Riverpoint Medical in Northeast Portland is hiring for Regulatory Affairs Associate. This position will be onsite at our new office, The Point. 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.

Requirements

Minimum 1-5 years’ knowledge and experience in Regulatory Affairs in the manufacture of medical devices.
Understanding of FDA QSR (21 CRF 820), MDR, ISO13485, and MDSAP.
Ability to create technical dossiers 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

Identify and prepare 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 submit 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 annual 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.
Make quality regulatory decisions, balancing risks, and benefits.