Regulatory Affairs Specialist

Job Description

Job Description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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. As a Kelly employee, you will 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. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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