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Regulatory Affairs Executive

Onsite, Kuala Lumpur, Kuala Lumpur

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Job ID: R-549136
Category: Regulatory Affairs
Location: Kuala Lumpur, Malaysia
Region: APAC

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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.

Job Description

Responsibilities:

To be responsible for regulatory affairs of BD in Malaysia and Singapore.
Provide support to regional RA team in ASEAN countries.
Be able to provide training/mentoring for new RA staffs joining the company.
Be able to perform regulatory tasks independently such as product registration, submission of license renewal applications, preparation of reports etc.
Assist on timely submissions of new registrations and license renewals.
Ensure that all relevant documentation are submitted according to the regulations of each country.
Follow up on status of licenses and take necessary actions when required.
Keep abreast of changes in regulations and ensure compliance within the organization.
Coordinate with marketing teams to obtain relevant information and documentation for submission purposes.
Review promotional materials and labels for compliance.
Conduct gap analysis and implement any necessary remedial action plans where there are gaps identified between current and desired states.
Participate in local industry associations to keep abreast of developments in the medical device industry.
Support regulatory activities by other departments within the organization including Quality, Manufacturing, Marketing and Sales.
Undertake additional projects and tasks as assigned by the supervising manager
Provide regulatory inputs for and participate in GDP audits where appropriate

Qualifications:

• Minimum 4 years’ experience in Medical Device Industry.
• Experience working in a multinational environment will be advantageous.
• Proficiency in Microsoft Office Applications especially MS Word, Excel, PowerPoint and Outlook.
• Strong analytical skills and attention to detail.
• Good interpersonal and communication skills.
• Self-motivated and ability to work independently.
• Ability to multi-task effectively.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills