Job Description
Regulatory Affairs Specialist sought to work with BD's latest technologies across a broad portfolio of products, including Programmable Electrical Medical Devices, stand-alone software as medical device, and disposable infusion sets.
BD is a global medical technology company that advances the world of health. Our Purpose is to help people have healthier lives and improve the quality of care. We are looking for a Regulatory Affairs Specialist to join our team.
The Regulatory Affairs Specialist will be a key member of our cross-functional teams, working on new product development projects, sustaining engineering projects, and MDR compliance program. The role requires a strong understanding of regulatory requirements, including MDD / MDR, standards, and guidance.
Responsibilities:
- Compile and communicate regulatory requirements to cross-functional groups concisely and precisely.
- Prepare and present gap analysis assessments of regulations and guidance to peers and cross-functional groups.
- Review and approve project documentation, including design reports and labelling.
- Prepare regulatory submissions.
- Represent the regulatory function in NPD and sustaining projects.
Requirements:
- Relevant degree (BSC in Electronics or Biomedical engineering field) or equivalent proven experience.
- 3+ years' experience in a similar position, Medical Device is an advantage.
- Experience with regulatory submissions and exposure to programmable electrical equipment is an advantage.
- Knowledge and experience on EU MDR and standards (ISO 13485, ISO 14971 and IEC 60601 series).
- Knowledge of FDA and international regulatory requirements is a plus.
BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of protected status.