Senior Regulatory Affairs Specialist (Hybrid)

Recruiter
BD Medical
Employment Type
Permanent
Salary
Not disclosed
BD Medical logo

Job Description Summary
Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Our Research and Development (R&D) Centre of Excellence in Limerick provides groundbreaking technology and a creative environment to be inspired to tap into your inner genius. We are looking for amazing, passionate and dedicated people like you, where you will be at the forefront of creating and developing specialised devices, software solutions and systems to help others. You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!

Job Description

Limerick based with flexible hybrid working (1-2 days per week)

In this role, the Regulatory Affairs Specialist will be working with BD’s latest technologies across a broad portfolio of products which includes programmable electrical medical devices, stand-alone software as medical device, accessories and disposable infusion sets. This is a highly visible role within the organisation, and you will participate in multi-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc). The role will work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.

Responsibilities:

  • Inputting into development of regulatory strategies and providing guidance and expertise.
  • Compiling and communicating regulatory requirements (e.g. EU MDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
  • Maintaining Regulatory procedures to ensure continued compliance
  • Preparing and presenting gap analysis assessments of regulations, and guiding peers and multi-functional groups in a concise and precise manner.
  • Review and approve the project documentation (design reports, labelling, etc.).
  • Ensure that updates to the Technical Files and international registrations are conducted appropriately.
  • Develop tactics to support first to market commercial opportunities and minimising time to product launch.
  • Work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
  • Identify roadblocks, defining problems based on data / facts and effectively communicating with your peers, project teams or management (as appropriate) for seeking solutions.
  • Support continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
  • Mentor and develop team members.

About you

For this role you will hold a relevant degree (BSC in Electronics or Biomedical engineering discipline), or equivalent proven experience and have 2+ years’ experience in a similar position. You will have worked with regulatory submissions with exposure to mechanical and active devices (stand-alone softwares, instruments and disposable devices) and mobile applications. Knowledge and experience on EU MDR / UK MDR / EU MDD / MDSAP and standards(ISO 13485, ISO 14971, IEC 60601 series and IEC 62304…) is a plus.

Click on apply if this sounds like you!

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components – is designed to support the varying needs of our diverse and global associates.

Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.


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