Location: Dublin
Job Purpose
The rer will lead Regulatory Affairs activities and drive execution of related objectives to guide the company through the regulatory landscape to achieve successful product approvals and market access.
Responsibilities
- Develop and implement regulatory strategies for new and future medical devices in line with business objectives and market needs
- Provide regulatory guidance to the product development team including the management and assessment of process/design changes on product regulatory strategy
- Collaborate with the wider team to ensure that necessary and sufficient regulatory activities and documentation including product design and technical files are generated and maintained throughout the product lifecycles.
- 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.
- Ensure timely and accurate submissions of regulatory filing including IDEs and PMAs
- Keep up to date with changes and interpret relevant standards and ensure the company meets applicable regulatory requirements – communicate regulatory changes and their impact to internal stakeholders
- 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.
- Engage with the FIRE1 QMS to ensure delivery of the overall quality and regulatory strategy & support the achievement of the business quality and regulatory objectives
- Other ad-hoc duties as required
Experience & Education
Essential
- 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
Desirable
- Experience with medical device software and cybersecurity
- Experience in implantable medical devices
- Experience with medical electrical equipment
- Experience with clinical investigations of medical devices
Skills
- Strong knowledge of global regulatory requirements (e.g., FDA, EU MDR, ISO13485
- Strong communication and influencing skills – good listener
- Ability to work under pressure and meet deadlines
- Ability to manage multiple projects and deadlines
- Target driven individual who can work to own initiative
- Strong analytical and problem-solving abilities
- Ability to make decisions and own processes
- Thrives in a fast-paced start-up environment
Reporting
VP of Quality & Regulatory Affairs
