Senior Regulatory Affairs & Compliance Specialist (malaysia & Singapore)

Petaling Jaya, Malaysia

Job Description


3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter.

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3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:


  • Proven category leadership

  • Exposure to attractive end-markets

  • Innovation mindset driving improved patient outcomes

  • Collaborative customer relationships

  • Deep global regulatory experience

  • Operational excellence and strong cash flow

  • Strong sales growth and profitability with significant recurring sales


We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company\xe2\x80\x9d.

The Impact You\xe2\x80\x99ll Make in this Role
As MY/SG Regulatory Affairs & Compliance Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

  • Responsible for pre-market regulatory clearances and post-market regulatory activities.

  • Perform regulatory assessment and determine registration plans with business divisions for strategic implementation.

  • Articulate registration requirements and compile regulatory documents according to local regulatory requirements.

  • Submit registration dossier and follow through all in-process evaluation until regulatory clearance is obtained.

  • Act as the focal point for commercial support pertaining to all regulatory activities.

  • Manage regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity.

  • Responsible for post-market regulatory activities to ensure regulatory compliance.

  • Execute all warranted FSCA and follow-up all through until closure, including preparation and submission of relevant FSCA reports to regulatory authority.

  • Perform adverse event reporting and follow-up through until closure.

  • Review promotional materials to ensure all business claims in the range of registered scope.

  • Remain good rapport with regulatory authority and regulatory industry to assure the partnership and support effective regulatory policy.

  • Keep abreast of new regulations and provide necessary regulatory information, updates, and documentation to organization.

  • Support any other duties within the role or task assigned from time to time.


Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

  • Bachelor\xe2\x80\x99s degree or higher in Pharmacy, Life Sciences, or a related scientific field.

  • 2 \xe2\x80\x93 3 years of regulatory affairs experience in pharmaceutical and/or medical devices industry.


Additional qualifications that could help you succeed even further in this role include:

  • Knowledge of ASEAN medical devices regulatory requirement.

  • Excellent communication and collaboration abilities.

  • Independent and proactively working on regulatory support.

  • Team player to support different directions of group work.

  • Flexible attitude and ability to work in a rapidly changing regulatory environment.


Work location: Work Your Way eligible (Employee choice to work remote, on site, or hybrid)


Travel: May include up to 5% (domestic/international)


Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being
3M offers many programs to help you live your best life \xe2\x80\x93 both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.


Chat with Max
For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.

#LI-Hybrid
Learn more about 3M\xe2\x80\x99s creative solutions to the world\xe2\x80\x99s problems at www.3M.com or on Twitter @3M.
Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M\xe2\x80\x99s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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Job Detail

  • Job Id
    JD992698
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Petaling Jaya, Malaysia
  • Education
    Not mentioned