Senior Regulatory Specialist
Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy.
Role/Responsibilities
1. Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
2. Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
3. Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
4. Develop and manage product design and technical documentation in compliance with the relevant regulations and standards, ensuring that data is controlled and is appropriately protected from corruption, misuse or damage.
5. Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
6. Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.
Skills/Experience:
7. A Bachelor's or Master's degree in a scientific or engineering discipline.
8. At least 7 years' experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k) and PMA submissions.
9. Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
10. Collaborative team player with solid knowledge of the medical device design and development process.
11. Excellent written, interpersonal communication and presentation skills.
12. High level of organization with the ability to manage multiple projects.
13. Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents -
For further information please contact James Cassidy or call in confidence 086 0204322