Sr. Regulatory Affairs Consultant
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.
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