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Riverpoint Medical · 2 days ago

Regulatory Affairs Associate

Portland, OR

Full-time

Onsite

Entry, Mid Level

1+ years exp

Riverpoint Medical is a company specializing in the design and manufacturing of premium medical devices. They are seeking a Regulatory Affairs Associate to manage regulatory submissions, maintain registrations, and collaborate on technical documentation for medical devices.

BiotechnologyHealth CareManufacturingMedical Device

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

Qualification

Regulatory AffairsFDA QSR (21 CRF 820)ISO13485Technical DossiersRisk AssessmentCustomer CentricCustomer Service

Required

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