Regulatory Affairs Specialist

Description

An established medical device manufacturer is looking to appoint a Regulatory Affairs professional to support global product registration and market access activities. This role sits within a wider regulatory function and plays a key part in ensuring products can be registered, maintained, and updated across multiple international markets.

You will act as a central point of coordination for registration documentation, working closely with internal teams, regional contacts, and overseas authorities to manage submissions, track approvals, and respond to regulatory changes.

Key Responsibilities

Compile, organise, and manage documentation required for product approvals across international markets. Take responsibility for registration processes within designated regions, acting as the internal expert for local compliance requirements. Communicate directly with overseas regulatory authorities and health ministries to confirm guidelines, submit applications, and resolve any issues. Determine any testing or certification needed for market entry and coordinate with technical teams to ensure completion. Handle submissions through official regulatory portals, ensuring all data is accurate and complete. Provide support to the regulatory function by gathering and sharing information across quality, engineering, supply chain, and commercial teams. Create and maintain regulatory statements, justifications, and supporting documentation for both internal and external purposes. Keep detailed records of registration progress, approvals, renewals, and product codes. Track regulatory and industry developments, evaluating their potential impact on current registrations and internal processes.

Experience & Skills

Experience in regulatory affairs or a similar compliance role within medical devices or pharmaceuticals. Exceptional organisational skills and a sharp eye for detail. Ability to communicate clearly and influence stakeholders at all levels. Familiarity with global registration processes is a plus, but not essential.

This is a great opportunity for someone looking to build or deepen their career in regulatory affairs within a structured, internationally focused organisation. If it looks like an ideal opportunity please apply now.

Ad ID: 5417604696