Regulatory Affairs Specialist

4 days ago

Singapore Johnson & Johnson Full time

The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility.
- The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson & Johnson Medical devices, with responsibility to support the regulatory activities.
- Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
- Maintain departmental and source company databases of regulatory approvals
- Liaise and establish cooperative relationships with source company regulatory
- Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
- Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices
- Contribute to RA Team meetings to learn from colleagues, share experiences and best practice
- Coordinate the release for supply of unapproved medical devices under the Special Access Scheme (SAS)
- Leverages a solid working knowledge of the global regulatory environment, including proposed laws, regulations and guidance, to inform compliant Regulatory strategies to contribute to the development of business strategies

**Qualifications**
Bachelor's degree in biomedical engineering or equivalent in Science or related discipline.

3 years or more relevant work experience in Regulatory Affairs/ Quality/ Compliance in medical devices. Familiarity with the regulatory systems and product registration requirements in Singapore;
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 others;
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.

**Primary Location**
Singapore-Singapore-Singapore
- **Organization**
Johnson & Johnson Pte. Ltd. (8435)

**Job Function**
Regulatory Affairs

**Requisition ID**
2206046630W

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