Regulatory Affairs Associate at RIVERPOINT MEDICAL LLC

Portland, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

0.0

Posted On

15 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, FDA 510(k), EU MDR, Technical Documentation, Risk Analysis, Customer Service, Quality System, Clinical Evaluation, Post-market Surveillance, Product Labeling, Scientific Rationale, Regulatory Requirements, Medical Devices, ISO13485, MDSAP

Industry

Medical Equipment Manufacturing

Description

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. Duties and 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. Qualifications: * 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. * 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 9 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.

Responsibilities

The Regulatory Affairs Associate will identify and prepare regulatory submissions for various markets, including FDA and EU. They will also maintain regulatory documentation and collaborate with customers to ensure compliance with standards.