Regulatory Affairs Specialist

2 weeks ago

Kuala Lumpur, Malaysia BD Full time

**Job Description Summary**:
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

**Key responsibilities**:

- Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.
- Collect and organize labeling related documentation for core team member review.
- Perform gap analysis to support labeling projects.
- Review label specifications for adherence to labeling procedure requirements.
- Compile and categorize cross-functional feedback as an output to labeling review requests.
- Assist in regulatory activities related to US and OUS labeling remediation.
- Review protocols, reports, and journal articles to ensure collection of appropriate data to support promotional materials.
- Help draft and route standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Remain current on standards and regulations affecting advertising, promotion, and labeling and communicate the impact cross-functionally.
- Perform other duties and assignments as required.

**Professional Skills & Key Competencies**
- Excellent verbal and written communication skills.
- Demonstrated ability to analyze, interpret, and review scientific, technical, and regulatory literature and documents.
- Excellent attention to details.
- Flexible and adaptable to fulfill business priorities.
- Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).
- Manages time efficiently.

**Minimum Qualifications**:

- Bachelor’s degree in Life Sciences or Engineering.
- One (1) to three (3) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry.
- Excellent interpersonal, communication and analytical skills.

**Desired/Additional Skills & Knowledge**:

- Familiarity and background with advertising, promotion, and labeling in the medical device industry.

**Certifications**
- RAPS RAC a plus.

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.

**Primary Work Location**: MYS Kuala Lumpur - Jalan Kerinchi

**Additional Locations**:
**Work Shift**:

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