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Regulatory Affairs Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's or Master's in Regulatory Science or related field, 5+ years experience in medical device regulatory affairs, Proficient in 510k submissions and FDA Quality System.

Key responsabilities:

Design, develop and optimize medical devices to meet standards
Coordinate with technicians and cross-functional teams
Prepare study documentation and maintain regulatory files
Lead preparation of technical reports and regulatory filings

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Design and develop medical devices from concept through production release while adhering to design input requirements, project timelines, and quality standards
Interface with technicians to manufacture prototype medical devices
Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Completes study documentation and maintains regulatory study files in accordance with sponsor requirements and Institution policies.
Improve manufacturing processes
Conduct design analysis, modeling, and simulation to optimize device design and performance
Perform in vitro testing and analyze collected data
Collaborate with cross-functional teams (e.g., product, manufacturing, quality, regulatory, clinical partners) throughout the product development process
Lead the preparation of technical reports, design history files, and regulatory filings for medical device submissions
Participate in design reviews, risk assessments, and post-market surveillance activitie

Requirements:

Bachelor's degree or Master's degree in Regulatory Science or a related degree
5+ years of prior regulatory affairs experience in the medical device field
High proficiency in preparing and filing successful 510k submissions
Strong understanding of FDA Quality System requirements for Class II and Class III medical devices
Excellent communication skills and ability to work in a team environment