
Director of Quality and Regulatory Excellence
6 days ago
The Director of Quality and Regulatory Compliance will serve as a key member of the Global Sales leadership team. The incumbent is responsible for providing regulatory and quality leadership for the region.
- A comprehensive list of responsibilities includes:
- Ensuring compliance with global quality management systems and local regulations.
- Leading post-market vigilance activities to ensure timely execution according to local and corporate requirements.
- Maintaining a high-performing team through effective leadership and communication skills.
- Developing and implementing strategic plans for quality and regulatory compliance.
Key Responsibilities
- Regulatory Compliance (30%): Ensure adherence to global sales quality management systems and local quality management systems.
- Post-Market Vigilance (30%): Execute activities on a timely manner according to local and corporate requirements.
- People Leadership (25%): Foster a high-performing team through strong leadership and communication skills.
- Product Registration (15%): Ensure timely registration in compliance with regulatory requirements.
Required Skills and Qualifications
- Bachelor's degree in engineering or life science related field.
- Minimum 10 years hands-on experience in quality assurance, preferably in a medical device company.
- Strong influencing skills and ability to build strong interpersonal relationships.
- Excellent knowledge of FDA and EU regulatory compliance for medical devices.
- Demonstrated leadership in a cross-functional environment.
Working Conditions
- May work extended hours during peak business cycles and desk-bound tasks such as ISO certification audits and preparation of product registration documents.
- Occasional interstate and international travel may be required.
Benefits
- Opportunity to work on building a quality system from ground up.
- Chance to develop and implement strategic plans for quality and regulatory compliance.
Others
- Mature, proactive working attitude and ability to work under pressure.
- Resourceful and independent team player.
- Excellent communication skills including public speaking and written skills.
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