Regulatory Affairs Associate Manager

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The Regulatory Affairs Associate Manager (MedTech) is a member of the local Regulatory Affairs department (MedTech), supporting Regulatory Affairs Lead Singapore (MedTech) for:

- Leading the team in regulatory submissions for new/existing medical devices
- Providing input to global regulatory strategies and identifying Singapore requirements for successful regulatory filings for new products/indications/changes.

This position reports to the Regulatory Affairs Lead Singapore (MedTech).

**Responsibilities**:

- The Regulatory Affairs Associate Manager (MedTech) will be a member of the local Regulatory Affairs department (MedTech) within the Local Operating Company (LOC), with responsibility to support Regulatory Affairs Lead Singapore (MedTech) for leading the local regulatory affairs team in regulatory submission for new/existing products including regulatory compliance for existing product licenses throughout the product lifecycle.
- Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Singapore and request the documentation required for regulatory submissions.
- Leverage a solid working knowledge of the global regulatory environment, including proposed laws, regulations and guidance, to inform compliant regulatory strategies contributing to the development of business strategies.
- Engage marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
- Manage interactions with stakeholders and distribution centres as required to ensure product supply is not disrupted.
- Build constructive relationships with the local authorities and execute regulatory strategies in compliance with relevant laws, regulations and organizational requirements necessary to obtain, and maintain legal market status.
- Monitor and evaluate the changes of local regulatory requirements and industry standards and provide regulatory intelligence to SEA and global regulatory partners.
- Participate in industry discussions for policy shaping, as required.
- Deploy new or updated requirements via the Quality Management System.
- Establish and maintain SOPs on regulatory affairs departmental work processes and act as auditee/SME for regulatory issues in internal and external audits.
- Have oversight of departmental database to ensure proper tracking system is in place.
- Manage and develop direct reports including career growth.

**Qualifications**:

- Bachelor's degree or equivalent in Pharmacy, Life science or related discipline;
- Minimum 8 years of Regulatory Affairs experience in relevant MedTech / Orthopedics industry
- Excellent verbal and written communication skills - proficiency in written and oral English is required;
- Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by cross-functional teams;
- Demonstrated ability to handle multiple projects;
- Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;
- Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
- Proactive team player, able to take charge and follow through.