Job Description:
- Develop and implement regulatory strategies to secure product approvals more quickly than competitors.
- Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment.
- Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines.
- Collaborate with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure that regulatory requirements are incorporated into product development and lifecycle management.
- Represent regulatory affairs in global business and strategic leadership meetings while supporting the IVD sectors.
- Mentor and guide regulatory staff and teams across various product modalities.
- Set and establish departmental goals and objectives.
Job Requirements:
- A Master’s degree in a Science or Technology field.
- Previous experience in the Medical Device or Healthcare sector.
- At least ten (10) years of experience in Regulatory Affairs within the medical device industry.
- Proven ability to lead and develop teams across multiple countries
- Excellent verbal and written communication skills in English.
- Extensive regulatory experience across multiple APAC countries.
- Strong attention to detail and the ability to navigate a matrixed environment.
