Medical Device Regulatory Affairs Specialist

JOB DESCRIPTION:

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.
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.
Key Responsibilities
 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, RD, 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.
Qualifications
 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.
Preferred Experience
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.

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