Quality Assurance & Regulatory Affairs Manager/Director at Jobot
Needham, MA 02492
About the Job
New Quality Assurance Regulatory Affairs Manager Opportunity!
This Jobot Job is hosted by: Audrey Block
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $150,000 - $200,000 per year
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 Quality Assurance & Regulatory Affairs Manager 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 5 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 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, we would love to hear from you.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Audrey Block
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $150,000 - $200,000 per year
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
- 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
Job Details:
We are seeking Quality Assurance & Regulatory Affairs Manager 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 5 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 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, we would love to hear from you.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
150,000 - 200,000 /year