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

• Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
• Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
• Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
• 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.
• Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
• Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.

• A Bachelor’s or Master’s degree in a scientific or engineering discipline.
• 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.
• Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
• Collaborative team player with solid knowledge of the medical device design and development process.
• Excellent written, interpersonal communication and presentation skills.
• High level of organization with the ability to manage multiple projects.
• Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents -