Are you a skilled Regulatory Affairs professional looking to join a global leader in the medical device industry? Whether you're an established Regulatory Affairs Lead or a Senior professional looking to take the next step into a lead role, this dynamic opportunity offers the chance to play a pivotal part in ensuring compliance and regulatory excellence for cutting-edge healthcare products. As the Regulatory Affairs Lead, you will take ownership of technical documentation, collaborate with cross-functional teams, and contribute to the success of innovative healthcare solutions.

Responsibilities:

Own and maintain content of technical files for medical device products.

Collaborate with the global Regulatory Affairs team to incorporate region-specific requirements into product documentation.

Ensure regulatory compliance throughout the product lifecycle.

Lead the regulatory aspects of product development, working closely with Product Development and Product Management teams.

Manage and update technical files in line with product design and changes.

Provide guidance on regulatory processes, offering internal training and promoting awareness across the organisation.

Lead or participate in process improvement projects to streamline regulatory functions.

Support post-market surveillance activities and assist with audits and regulatory agency reviews.

Mentor junior members of the Regulatory Affairs team.

Skills:

3-5 years of experience in the medical device industry.

Strong background in medical device development and regulatory compliance.

Experience with regulatory submissions, change management, and risk management processes.

Tertiary qualifications in Regulatory Affairs, Engineering, Science, or a related discipline.

Apply directly now, or send your updated CV to Ben Byrne at [email protected] OR (04) 21776703