Medical Device Regulatory Affairs Specialist

Job Description

Job Description

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. \nCompany Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.