Regulatory Affairs Specialist

Medical Device Industry

Kelly Science is seeking an experienced Regulatory Affairs Specialist to support regulatory strategy, submissions, and ongoing compliance for a medical device organization. This position is ideal for a hands-on regulatory professional with 5-10+ years of experience who understands the requirements for bringing Class II and/or Class III medical devices to market and maintaining regulatory compliance throughout the product lifecycle.

Key Responsibilities

• Support regulatory strategy and pathway development for new and existing medical devices.

• Prepare, coordinate, and maintain regulatory submissions and supporting documentation for FDA and other applicable regulatory authorities.

• Support FDA submissions and regulatory activities associated with Class II and Class III medical devices.

• Serve as a regulatory subject matter resource for cross-functional teams throughout product development, validation, manufacturing, and commercialization.

• Ensure products and associated documentation comply with applicable FDA regulations and quality system requirements.

• Maintain knowledge of 21 CFR Part 820, ISO 13485, ISO 9001, and other applicable standards and regulatory requirements.

• Monitor changes to regulations, standards, and FDA guidance and communicate potential impacts to internal stakeholders.

• Support regulatory documentation, technical files, dossiers, change assessments, and product lifecycle activities.

• Partner with Quality, Engineering, Manufacturing, Operations, and other functions to ensure regulatory requirements are incorporated into projects and product changes.

• Review product and process changes for potential regulatory impact and determine appropriate documentation or submission requirements.

• Support internal, customer, supplier, and regulatory audits as needed.

• Assist with CAPA, complaint investigations, document control, supplier quality, and other Quality System activities where regulatory expertise is required.

• Review and support IQ/OQ/PQ and validation documentation for regulatory and Quality System compliance.

• Support risk-management activities, including FMEA and related product/process documentation.

• Maintain accurate, inspection-ready regulatory records and documentation.

• Communicate with regulatory agencies as appropriate and assist with responses to agency questions and requests.

• Perform other regulatory and quality-related duties as assigned.

Qualifications

• 5-10+ years of relevant Regulatory Affairs experience, preferably within the medical device industry.

• Demonstrated experience with FDA-regulated medical devices and applicable U.S. regulatory requirements.

• Experience with Class II and/or Class III medical devices strongly preferred.

• Working knowledge of 21 CFR Part 820, FDA Quality System requirements, ISO 13485, and ISO 9001.

• Experience preparing or supporting medical device regulatory submissions and associated technical documentation.

• Understanding of medical device product development, manufacturing, validation, and commercialization processes.

• Experience working within an established Quality Management System.

• Ability to interpret regulatory requirements and translate them into practical requirements for cross-functional teams.

• Strong technical writing, documentation, organization, and project-management skills.

• Excellent written and verbal communication skills with the ability to work effectively across Quality, Engineering, Manufacturing, and business teams.

• Strong attention to detail and ability to manage multiple regulatory priorities and deadlines.

Education

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Sciences, Regulatory Affairs, or a related technical discipline required.

• Advanced degree or relevant regulatory/quality certifications are a plus.

Preferred Experience

Candidates with experience in one or more of the following areas are especially encouraged to apply:

• FDA medical device submissions

• Class II and Class III devices

• ISO 13485 Quality Management Systems

• Design controls and risk management

• IQ/OQ/PQ and process validation

• CAPA and complaint handling

• Internal or regulatory audits

• Supplier quality

• Regulatory change assessments

• Technical documentation and regulatory dossiers

Kelly Science connects experienced scientific, engineering, quality, and regulatory professionals with opportunities where their expertise can make an impact. We are looking for a regulatory professional who can work independently, collaborate across functions, and help ensure medical devices meet applicable regulatory requirements from development through commercialization.

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