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.
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