Regulatory Affairs Specialist

Kuala Lumpur, Malaysia

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\xe2\x84\xa2 is our Purpose, and it\xe2\x80\x99s no small feat. It takes the imagination and passion of all of us\xe2\x80\x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per year\xe2\x80\x94to 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\xe2\x80\x99ll 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\xe2\x80\x99s 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.
Click on apply if this sounds like you!

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.

To learn more about BD visit:

Primary Work Location MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift

BD

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Job Detail

  • Job Id
    JD1015622
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Kuala Lumpur, Malaysia
  • Education
    Not mentioned