Regulatory Affairs Specialist (Contract)

April 19

MCRA

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Leading Global Full-Service Medical Device, Diagnostics & Biologics CRO & Integrated Consulting Advisory Firm.

Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200

Description

• Support project teams by actively participating in the development process to uphold company adherence to established policies and procedures. • Create and upkeep product labeling, encompassing package labels and inserts, to align with regulatory requirements. • Review product promotional materials and specifications to ensure compliance with relevant regulations and policies. • Accurately classify medical devices based on their functions and characteristics. • Assemble and manage regulatory files, including 510(k) submissions and Change Notifications. • Develop and maintain communication channels with regulatory agencies, covering pre-submission strategies, compliance test requirements, potential regulatory pathways, and clarifications and follow-ups on submissions under review. • Analyze, identify, and interpret pertinent regulatory guidelines and FDA guidance documents. • Coordinate and document internal regulatory processes, encompassing license renewals and registrations. • Compile and oversee the maintenance of regulatory databases or systems for efficient management. • Ensure compliance with a range of regulations, including 21 CFR Part 820, 21 CFR 801, 21 CFR Part 807, Section 520(b) of the FD&C Act, EU MDR 2017/745, EU MDD 93/42/EEC, UK MDR 2002, SOR/98-282, and TG(MD)/R 2022.

Requirements

• Bachelor's degree in Engineering, Biology, Regulatory Science, or equivalent. • Regulatory Affairs background is beneficial but not mandatory. • Familiarity with 21 CFR Part 820, 21 CFR 801, 21 CFR Part 807, Section 520(b) of the FD&C Act, and ISO 13485 is preferred. • Basic comprehension of orthopedic and software devices; prior experience in the medical device industry is preferred. • Proficiency in Excel, Word, PowerPoint, Outlook, and customer database management systems. • Understanding and familiarity with all facets of product development, encompassing manufacturing practices, regulatory requirements, and approval processes.

Benefits

• Not specified