EPM Scientific are currently supporting an Orthopedic Medical Device manufacturer in hiring a Regulatory Affairs Consultant to join their Post Market RA team, focusing on Intelligence, Monitoring, Submissions, and Notified Body interactions.
Responsibilities:
* Develops regulatory strategies by assessing intelligence, evaluating environments, and advising across the product lifecycle.
* Anticipates obstacles, identifies market access challenges, and proposes compliant solutions.
* Determines product classification, submission pathways, and jurisdictional requirements globally.
* Provides regulatory guidance to cross-functional teams on product development, compliance, labelling, and claim substantiation.
* Supports advocacy efforts and trains stakeholders on evolving regulatory requirements and SOPs.
* Assesses quality, preclinical, and clinical documentation for submission readiness (primarily EU and US).
* Strategizes filing approaches for proposed changes and ensures alignment with applicable regulations.
* Manages communications and negotiations with regulatory authorities throughout development and review of documentation.
* Oversees regulatory submissions and tracks agency feedback.
Contract:
* 12 months, with expectation to extend to 2 years or longer
* Full time hours
* Hybrid on site in Cork
* Start dates late August/early September
Ideal candidates possess EU & US submissions experience, strong communication and project management skills, and an ability to work independently. Orthopedic experience, ideally Class III, is highly desired.
Desired Skills and Experience
EU MDR, Class III Medical Device, Orthopedics, US Submissions, FDA, 510(k), Regulatory Affairs, Notified Body, Technical Files