Manager - Regulatory Affairs and Compliance

1 week ago

Gurgaon, Haryana, India 3M Full time
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:

About the Role:

Reporting into the Asia RAQC Manager, you will be responsible for the Regulatory Affairs & Compliance for India region, including to support 3M Health Care Business Spin Co and distributors management. The job holder will represent 3M HCB 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 import/export health care businesses, and directly related to safeguard 3M Soin Co free from regulatory risk and improve the long-term financial performance for India region.

Job Description

1. Hold Regulatory Affairs accountable in all pre-market registration and post-market surveillance to ensure all business and regulatory activities to meet India and sub-countries' regulatory requirement.

2. Develop and execute the registration plans and regulatory projects to support health care business.

3. Sense and monitor the local regulations to ensure 3M Spin Co ahead of 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 communication flow.

8. Manage and support the RA work owned by consultant or distributor to ensure the diligent work to support business plans.

9. Proactively communicate with all stakeholders and establish good rapport with regional and country stakeholders to align with the business and RA goals. 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 NPAA to support business pricing strategy.

Qualifications:

Education: Bachelor of Science or Biomedical Engineering related

Relevant Experiences in Medical Device regulatory experience required:

1. Around 8-10 years of working experiences in a function related to regulatory affairs from healthcare industry.

2. About 5-8 year of leadership experiences to support business growth, preferable from medical device industry.

3. Knowledge of regulatory management in medical device product registration and total life cycle management.

4. Strong execution capability to hand-on and project management

5. Strong communication and inter-personal skills

6. Independent and proactively working on business solution

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