Quality Assurance & Regulatory Affairs Manager

A bit about us :

We are a well established consulting firm that provides solutions to medical device company, pharmaceuticals and biologics.

Why join us?

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

Job Details

Job Details :

We are seeking a highly motivated and experienced Quality Assurance & Regulatory Affairs Manager to join our dynamic team.

This is a permanent, full-time position 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 5 years of experience in quality assurance and regulatory affairs in the scientific / medical device industry.

3. In-depth knowledge of cGMP requirements, SOP, FDA, PMAs, and other relevant regulations.

4. Proven experience with medical devices and aesthetic products, including dermal fillers.

5. Strong leadership and team management skills.

6. Excellent problem-solving and decision-making abilities.

7. Ability to handle multiple tasks and projects simultaneously.

8. Excellent written and verbal communication skills.

9. Proficiency in using various software and databases for quality assurance and regulatory affairs.

10. Certification in quality assurance and / or regulatory affairs will be an asset.

This is an exciting opportunity for a seasoned Quality Assurance & Regulatory Affairs Manager 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 and aesthetic products, we would love to hear from you.