Regulatory Affairs Contractor

Our client, a Medical Devices / Healthcare company, is looking for a Regulatory Affairs Contractor for their Remote location.
 
Responsibilities:

• The Regulatory Affairs Contractor will provide regulatory support for medical device portfolio and business integration activities.
• The role will work closely with Regulatory Affairs and cross-functional partners to support global regulatory planning, product registrations, lifecycle management, and execution of integration-related regulatory activities.
• Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems.
• Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation.
• Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements.
• Assess regulatory impact of product, manufacturing, labeling, supplier, site, and quality system changes.
• Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions, as applicable.
• Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access.
• Support EU MDR and other global regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications, as applicable.
• Review existing regulatory documentation, identify gaps, and coordinate actions required to support integration and ongoing compliance.
• Maintain regulatory trackers, plans, and deliverables and ensure activities are completed according to established timelines.
• Partner with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration activities.
• Identify and escalate regulatory risks, dependencies, and potential impacts to business or integration timelines.

• The ideal candidate will have hands-on medical device Regulatory Affairs experience and be comfortable independently managing multiple global regulatory deliverables in a fast-paced, cross-functional environment.
• Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline.
• 3–5+ years of medical device Regulatory Affairs experience preferred.
• Experience with global medical device registrations and lifecycle management.
• Working knowledge of FDA medical device requirements and EU MDR; experience with additional international markets preferred.
• Experience with regulatory change assessments, global regulatory planning, and/or business or product integration activities preferred.
• Ability to independently manage multiple regulatory deliverables and collaborate effectively across global teams.
• Strong organizational, written communication, and problem-solving skills.
• Experience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and integration or transition of established medical device portfolios is highly desirable.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities