The Role:
· Reporting into the Asia RAC Manager, you will be responsible for the Healthcare Business Regulatory Affairs & Compliance to support export businesses based in Singapore
· The job holder will represent 3M Healthcare (Spin Co) in all official communications and issues with health care regulatory authorities.
· Successful execution in this role is key to perform the effective and efficient operations of the regulatory and quality compliance to mainly manage export health care businesses, and directly related to safeguard 3M Healthcare Limited (Spin Co.) free from regulatory risk and improve the long-term financial performance.
Job Description
1. Hold Regulatory Affairs accountable in all pre-market registration and post-market surveillance to meet Export countries, such as Indonesia and Philippines, regulatory requirement and ensure business success.
2. Develop and execute Spin Co regulatory strategy and related projects to support Export health care business development.
3. Sense and monitor the Export country regulations to ensure 3M Healthcare Limited (Spin Co) ahead of regulatory changes and manage the impacts.
4. Advocate the regulatory policy change to align with international standard and harmonization to reduce the regulatory barrier and support effective work.
5. Remain good rapport with regulatory authority and health care industry to assure the industry teamwork and partnership to support regulators’ initiative for global harmonization.
6. Serve as an active member in regional RAC team, interacting regularly with the business and function stakeholders to ensure the organizational goals achieved to support business growth.
7. Develop the standard operating procedures to streamlines the operational process and smoothen the communication flow.
8. Manage and support the RA work owned by consultant or distributor to ensure the diligent work and priority plan to support business goals.
9. Proactively communicate with all stakeholders and establish good rapport with regional and country stakeholders to support RAC strategic plans.
10. Demonstrate the leadership behavior if significant deviation happens that may impact compliance status or significant business risk.
11. Support market access activity and liaise the communication with 3rd party distributors to support business pricing strategy.
Qualifications:
Education: Bachelor of Science or Biomedical Engineering related. Pharmacist is a plus.
Relevant Experiences in Medical Device or Pharmaceutical regulatory experience required:
- Around 8-10 years of working experiences in a function related to regulatory from healthcare industry.
- About 5-8 year of leadership experiences to support business growth, preferable from medical device industry
- Knowledge of regulatory management in medical device product registration and total life cycle management.
- Strong execution capability to hand-on and project management
- Strong communication and inter-personal skills
- Independent and proactively working on RAC solutions