Regulatory Affairs and Compliance Associate

Regulatory Affairs and Compliance Associate

3M
4-5 years
Not Specified

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.
Job Description:
Regulatory Affairs and Compliance Associate
The Role:
  • Reporting into the RAC leader, you will be responsible for the Regulatory Affairs & Compliance (RAC) for Health Care Business (HCB) and Consumer Health and Safety Business (CHSD)
  • Successful execution is key to perform RAC function to support business growth, mitigate the compliance risk and achieve long term financial goals for 3M HCB and CHSD business.

Responsibilities:
1. Responsible for all regulatory activities pertaining to the relevant HCB & CHSD regulatory licenses and requirements.
2. Responsible for all pre-market registration clearances for all imported products and OEM products in the country, e.g.:
  • Determine registration plans with business segments to ensure right business direction to achieve company goals.
  • Articulate the registration requirements to ensure the collected information useful for submission plan.
  • Review registration document and able to address the gap of technical deficiencies.
  • Compile documentation and ensure completeness of registration dossier.
  • Submit registration dossier and follow through until regulatory clearance is obtained.
  • Establish and maintain Registration Planner and Listing for relevant countries as deemed appropriate.

3. As appropriate, act as the main focal point for internal stakeholders and external distributors and vendors pertaining to HCB & CHSD pre-market regulatory activities shown below, e.g.:
  • Execute the submission of registration dossier for new product registration and product change plan.
  • Follow-up and ensure that submission is done, and regulatory clearance obtained.
  • Support to smoothen the registration assessment in registration cycle
  • Review and approve promotional materials to ensure all documentation in line with registration claims and country regulatory requirements.
  • Collaborate to ensure the custom labeling activities in line with country regulatory requirement.
  • Monitor and promptly respond the changes in regulatory environment and participant in relevant industry meetings and take action to react to changes to ensure that 3M complies with relevant requirements.

4. Develop and maintain regulatory systems and tools to drive operational excellence for effective data tracking and remain regulatory data integrity
5. Monitor and promptly respond the regulation changes and participant in relevant industry meetings and take action to react to changes to ensure that 3M complies with relevant requirements.
6. Remain good rapport with regulatory authority and regulatory industry to assure the partnership and improve the transparent communication of regulatory policy.
Qualifications:
- Bachelor of Science in Pharmacy is preferred, or Biomedical Science related also welcome.
- Relevant Experiences in health care industry required
- Minimum 4-5 years of regulatory affairs working experiences, preferably in medical device industry Experience in advertisement approval of medical device is an advantage Knowledge of AMDD (ASEAN Medical Device Directive)
- Good command of English
- Good inter-personal skills, well-managed and composed Decision maker with high responsibility Independent and proactively working on regulatory support
- Team player to support multiple tasks and lead the regulatory direction of business work Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M.
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 Details

Employment Types:

Industry:

Other

Function:

IT

About 3M

At 3M we apply science in collaborative ways to improve lives daily as our employees connect with customers all around the world. Learn more about 3M's creative solutions to global challenges at www.3M.com or on Twitter @3M or @3MNews.

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