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.