Senior Regulatory Specialist

You are motivated by delivering high quality, innovative technology that consistently meets the needs of customers, impacting clinical outcomes.  You are an experienced regulatory professional that enjoys collaborating with cross-functional teams, including R&D, Quality, Operations, Clinical and Marketing, to meet strategic company goals.

Join WhiteSwell, a dynamic, rapidly growing organisation, as we develop a breakthrough therapy to treat acute decompensated heart failure patients world-wide.

What you’ll do

• 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.

What you bring

• 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.