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.