Director of Regulatory & Quality

Clearwater, SC - USA

Yearly Salary: $ 135000 - 150000

Posted on: 18-10-2025

Vacancies: 1 Vacancy

Job Summary

About the Role:
The Director of Regulatory & Quality will lead all regulatory affairs and quality assurance functions for a medical device organization ensuring full compliance with FDA ISO and international regulatory standards. This senior-level position is responsible for developing and implementing quality management systems regulatory submissions and compliance strategies to support product safety performance and market access. The role requires strong leadership deep expertise in medical device regulations and the ability to guide cross-functional teams in maintaining exceptional quality and compliance standards across all operations.

Responsibilities:

Oversee all regulatory and quality assurance activities related to medical devices ensuring adherence to FDA QSR (21 CFR 820) ISO 13485 and EU MDR requirements.
Develop implement and maintain quality management systems and regulatory policies aligned with U.S. and international medical device standards.
Lead preparation submission and maintenance of FDA 510(k) Technical Files and international product registrations.
Manage internal and external audits supplier quality audits and management reviews to maintain compliance and continuous improvement.
Collaborate with engineering manufacturing and supply chain teams to ensure design control risk management and validation processes meet regulatory expectations.
Oversee post-market surveillance complaint investigations CAPA nonconformance and change control processes.
Serve as the main contact with regulatory agencies notified bodies and certification authorities during audits and inspections.
Ensure compliance with OSHA EPA and other safety and environmental regulations as they relate to product quality and facility operations.
Lead and mentor the regulatory affairs and quality assurance team to achieve departmental and organizational goals.

Qualifications:

Bachelors degree in Engineering Life Sciences or a related technical discipline.
10 years of progressive experience in regulatory affairs and quality assurance within the medical device industry.
Proven success with FDA submissions including 510(k) and international regulatory documentation.
Expert knowledge of FDA QSR ISO 13485 EU MDR MDSAP and related global standards.
Experience conducting supplier audits and maintaining supplier quality compliance.
Strong understanding of ASTM UL CSA ANSI and EPA regulations relevant to medical devices.
Demonstrated leadership experience managing teams and multiple concurrent projects.
Excellent communication analytical and problem-solving skills.

Desired Qualifications:

ASQ Certified Quality Manager (CQM) or equivalent ASQ certification preferred.
Masters degree in Regulatory Affairs Quality Management or Biomedical Engineering.
Experience with PPAP processes supplier quality engineering and process validation.
Familiarity with OSHA and environmental safety compliance in regulated manufacturing environments.
Proven ability to develop regulatory strategies that support new product introductions and global market expansion.

Bonus
Equity
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

About the Role:The Director of Regulatory & Quality will lead all regulatory affairs and quality assurance functions for a medical device organization ensuring full compliance with FDA ISO and international regulatory standards. This senior-level position is responsible for developing and implementi...

Responsibilities:

Oversee all regulatory and quality assurance activities related to medical devices ensuring adherence to FDA QSR (21 CFR 820) ISO 13485 and EU MDR requirements.
Develop implement and maintain quality management systems and regulatory policies aligned with U.S. and international medical device standards.
Lead preparation submission and maintenance of FDA 510(k) Technical Files and international product registrations.
Manage internal and external audits supplier quality audits and management reviews to maintain compliance and continuous improvement.
Collaborate with engineering manufacturing and supply chain teams to ensure design control risk management and validation processes meet regulatory expectations.
Oversee post-market surveillance complaint investigations CAPA nonconformance and change control processes.
Serve as the main contact with regulatory agencies notified bodies and certification authorities during audits and inspections.
Ensure compliance with OSHA EPA and other safety and environmental regulations as they relate to product quality and facility operations.
Lead and mentor the regulatory affairs and quality assurance team to achieve departmental and organizational goals.

Qualifications:

Bachelors degree in Engineering Life Sciences or a related technical discipline.
10 years of progressive experience in regulatory affairs and quality assurance within the medical device industry.
Proven success with FDA submissions including 510(k) and international regulatory documentation.
Expert knowledge of FDA QSR ISO 13485 EU MDR MDSAP and related global standards.
Experience conducting supplier audits and maintaining supplier quality compliance.
Strong understanding of ASTM UL CSA ANSI and EPA regulations relevant to medical devices.
Demonstrated leadership experience managing teams and multiple concurrent projects.
Excellent communication analytical and problem-solving skills.

Desired Qualifications:

ASQ Certified Quality Manager (CQM) or equivalent ASQ certification preferred.
Masters degree in Regulatory Affairs Quality Management or Biomedical Engineering.
Experience with PPAP processes supplier quality engineering and process validation.
Familiarity with OSHA and environmental safety compliance in regulated manufacturing environments.
Proven ability to develop regulatory strategies that support new product introductions and global market expansion.