Regulatory Affairs Director
3 weeks ago
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.
Tell employers what skills you have
Management Skills
Leadership
FDA
Strong Attention To Detail
Quality Assurance
Regulatory Affairs
Healthcare
Regulatory Strategy
Strategy
Virology
Gastroenterology
Product Development
Regulatory Requirements
Life Sciences
Stakeholder Management
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