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Regulatory Affairs Executive

2 weeks ago

Kuala Lumpur, Malaysia BD Malaysia Full time

Job Description Summary

Job Description

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.

Why Join Us?

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.

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.

Become a maker of possible with us

**Responsibilities**:
- Ensure compliance with local regulations regarding medical device registration requirements- Maintain accurate records related to product registrations- Monitor changes in relevant legislation and communicate these changes internally- Coordinate with external stakeholders such as government agencies, consultants, distributors etc., on behalf of the organization- Provide advice/support to internal departments regarding regulatory matters- Review documentation submitted for approvals/licenses/certificates/permits etc., prior to submission- Collaborate with cross functional teams to ensure timely completion of tasks associated with product registrations- Work closely with manufacturers, suppliers, importers, exporters and other interested parties to facilitate smooth operations- Provide regulatory inputs for and participate in GDP audits where appropriate- Participate in local industry associations to keep abreast of developments in the medical device industry.

Qualifications- Bachelor’s degree in Science, Life Science or equivalent preferred- At least 5 years of experience in Regulatory Affairs preferably in the medical device industry- Experience working on IVD's registration would be advantageous- Strong understanding of local regulatory frameworks governing medical devices- Excellent communication skills both written and verbal- Ability to manage multiple projects simultaneously while meeting tight deadlines- Detail oriented approach to work with a focus on accuracy and precision- Highly organized individual capable of managing large amounts of data effectively- Proven track record of successfully implementing complex processes- Demonstrated ability to influence others through effective collaboration and negotiation techniques- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting._

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action 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, military eligibility or veteran status, or any other protected status.

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**Required Skills**:
Optional Skills


Primary Work Location

MYS Kuala Lumpur - Damansara Heights

Additional Locations

Work Shift