Regulatory Affairs Specialist

2 months ago

Laguna Hills, United States Actalent Full time

Description:

This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device industry and have Class II or Class III device experience. Candidate will:

Prepare documentation for regulatory submissions and registrations (FDA, EU, and Canada regulatory entities)

IDE, PMA, 510(k), Design Dossiers, Technical Files.

Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.

Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.

Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.

MDR transition project to maintain Adagio compliance.

Post-market and vigilance reporting process.

Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

Skills:

regulatory submission, medical device, fda, Regulatory affairs, Regulatory compliance

Top Skills Details:

regulatory submission,medical device,fda

Additional Skills & Qualifications:

2+ years experience Regulatory Medical Device

FDA experience

Bachelors Degree

Quality Systems MDR

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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