Regulatory Affairs Specialist

1 day ago

Kulim, Kedah, Malaysia BD (Formerly known as Bard Sdn Bhd) Full time 90,000 - 120,000 per year

Regulatory Affairs Specialist – Onsite– Malaysia (Fixed-term 2 years)

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's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve.

Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting.

The Regulatory Affairs Specialist in this position is responsible assisting with implementation of regulatory strategies including domestic and international submissions and other support of product project team.

Key responsibilities will include:


• Position will primarily serve as a liaison between Malaysia plant personnel and UCC Design Center RA with full over-sight from UCC Design Center RA Department. All work, assessments and materials will be approved by Design Center RA.


• May provide assessment for plant changes with oversight and approval of assessment by Design Center RA.


• Assist in providing regulatory support through the product life cycle on product project teams under supervision of Design Center RA


• Assist in the provision of international submissions as assigned by Design Center


• Assist in providing support for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations as assigned by Design Center


• Other project assessments as assigned by Design Center RA. Education and Experience required:


• BS in a scientific discipline with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalent


• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation


• Must have excellent written and verbal communication skills


• Must be self-motivated and have the ability to take ownership of her/his responsibilities


• Must be able to prioritize and handle several projects concurrently


• Must have technical writing skills and be proficient at compiling thorough regulatory change assessments describing change impacts on finished device safety and effectiveness Education and Experience preferred:


• Knowledge of the U.S. and European medical device regulations required

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve 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.

You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.

At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

 Location: Kulim (Kedah)

 Duration: 2-Years Fixed-Term Contract

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