Job Description
Job Description Summary
The Regulatory Affairs Specialist will work with BD's latest technologies across a broad portfolio of products, including Programmable Electrical Medical Devices, stand-alone software as a medical device, and disposable infusion sets. This is a highly visible role within the organisation, participating in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).
We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes the imagination and passion of all of us to look at the impossible and find transformative solutions that turn dreams into possibilities.
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric mindset.
About the Role
The Regulatory Affairs Specialist will work with BD's latest technologies across a broad portfolio of products, including Programmable Electrical Medical Devices, stand-alone software as a medical device, and disposable infusion sets. This is a highly visible role within the organisation, participating in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).
Responsibilities:
- Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc.) to cross-functional groups concisely and precisely.
- Reviews and approves project documentation (design reports, labelling, etc.).
- Prepares regulatory submissions.
- Prepares and maintains regulatory files
- Represents the regulatory function in NPD and sustaining projects
Preferred Requirements:
- Hold a 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.