Regulatory Affairs Specialist

About the role

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.

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

Benefits

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. Employees also have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. Employees are entitled to earn paid sick leave under the applicable state or local plan.