Regulatory Affairs Specialist
This highly innovative medical device manufacturer is actively looking for a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be working with multiple product development teams supporting regulatory approvals as well as maintaining clinical literature and clinical evaluation reports. You will also be responsible for planning, managing and support of clinical trials.
On offer is a highly competitive salary and benefits package as well as the opportunity to work on genuinely innovative products.
Responsibilities:
- Interpret regulatory requirements, identify and obtain the data needed to enable regional regulatory registrations of products
- To collaborate, author and/or review clinical evaluation reports for new product development
- Develop with the medical device legal manufacturer the regulatory strategy and approval pathways to enable product registrations
- Compile and coordinate the submission of regulatory applications to international regulatory agencies to enable product registrations
- Give guidance to product development teams to aid effective project planning, including timing and relative challenges of regulatory requirements
- Provide expert regulatory guidance to staff on the impact of proposed device and process changes to enable appropriate decision making and planning.
- Provide regulatory input to new product development teams in key areas, e.g. labelling, clinical evidence, risk management, biological safety and sterilisation to enable effective project planning.
- Monitor the regulatory landscape of international Medical Device markets and disseminate the impact of significant changes to personnel to enable appropriate decision making and planning.
- Maintain collaborative relationships with Product Management, Design & Development and Quality Departments and external partners, providing solutions to challenges.
- Interpret customer regulatory requests giving direction on their fulfilment.
- Support to the establishment, review and revision of the clinical evaluation per MDD/MDR.
- Provide support during ISO 13485 and other QMS/regulatory compliance audits and inspections
Qualifications/Experience:
- 2+ years’ experience within regulatory affairs
- A sound understanding of the key regulatory environments
- An ability to provide innovative solutions within the constraints of the regulations
- Experience within the medical device industry
- Experience with MMD, MDR, FDA 510K, CE marking, ISO 14917, ISO 13485 etc.
- Ideally degree educated within a science or engineering discipline