As Regulatory Affairs Manager , you will develop and implement regulatory strategies for new and future medical devices in line with business objectives and market needs.
Responsibilities:
- Provide regulatory guidance to the product development team including the management and assessment of process/design changes on product regulatory strategy.
- Lead the development, review and submission of clinical and regulatory files to relevant regulatory bodies and driving to successful approvals through management of interactions with regulatory agencies.
- Develop and maintain Standard Operating Procedures (SOPs) related to regulatory affairs.
- Engage with and prepare for interactions with notified bodies and regulatory authorities including audits, inspections, presubmission meetings.
Requirements:
- Bachelor’s Degree in Engineering, Science or regulatory related field.
- 5-7 years’ experience in medical device regulatory role.
- Recent regulatory experience including FDA regulations, Medical Device Regulation and other applicable national and international regulations and Standards.
This role will operate on a hybrid working model with office attendance required 2-3 times per week.
