Senior Director Quality Assurance & Regulatory Affairs

We are a well established consulting firm that provides solutions to medical device company, pharmaceuticals and biologics. We are looking for a Senior Director of Quality and Regulatory Affairs to join our team!

Opportunity to wear different hats in a small company-lots of growth!
Strong benefits and compensation package
Opportunity to work in multiple therapeutic and diagnostic areas

• Experience in writing PMAs
• Background in both regulatory and QA.
• Must have experience with design controls
• Must have a history with testing devices to universal standards
• While medical device history is the primary requirement, some history with pharmaceuticals or biologics would also be useful

Job Details:
We are seeking a Senior Director of Quality Assurance & Regulatory Affairs to join our dynamic team. This is a permanent, full-time position, but we are also open to contract basis, that will play a crucial role in ensuring the quality and safety of our medical devices and aesthetic products, including dermal fillers. The successful candidate will be responsible for overseeing all aspects of quality assurance and regulatory affairs, ensuring compliance with cGMP requirements, SOP, FDA, PMAs, and other relevant regulations.

Responsibilities:
1. Develop and implement quality assurance policies and procedures to ensure compliance with cGMP requirements, SOP, FDA, PMAs, and other applicable regulations.
2. Lead regulatory affairs activities, including the preparation of regulatory submissions and interactions with regulatory authorities.
3. Oversee the validation and verification of medical devices and aesthetic products, including dermal fillers.
4. Conduct internal audits and inspections to ensure adherence to quality standards and regulatory requirements.
5. Coordinate with cross-functional teams to resolve quality and regulatory issues.
6. Keep abreast of changes in regulatory legislation and guidelines, and ensure that these changes are communicated and implemented within the organization.
7. Provide training and guidance to staff on quality assurance and regulatory affairs matters.
8. Lead continuous improvement initiatives to enhance the efficiency and effectiveness of our quality and regulatory processes.

Qualifications:
1. Bachelor's degree in a scientific or related field. An advanced degree will be an added advantage.
2. Minimum of 10 years of experience in quality assurance and regulatory affairs in the medical device industry
3. Strong experience in writing PMAs
4. Must have experience with design controls
5. Must have a history with testing devices to universal standards
6. In-depth knowledge of cGMP requirements, SOP, FDA, PMAs, and other relevant regulations, PMA's is a requirement
7. Proven experience with medical devices and aesthetic products, including dermal fillers.
8. Excellent problem-solving and decision-making abilities.
9. Ability to handle multiple tasks and projects simultaneously.

This is an exciting opportunity for a seasoned Director of Quality Assurance & Regulatory Affairs to make a significant impact on our company's success. If you have the required skills and experience, and you are passionate about ensuring the quality and safety of medical devices, we would love to hear from you.