Actalent
Job Title: Quality/Regulatory Manager
Job Description
The Head of Quality & Regulatory Affairs is responsible for leading and managing all aspects of quality assurance, regulatory compliance, validation, and document control. This role ensures that products meet the highest standards of quality and safety while maintaining compliance with global regulatory requirements.
Responsibilities
Ensure the quality and compliance of all products and manufacturing processes.
Provide guidance and support to internal departments across the organization.
Represent the company in interactions with regulatory bodies and external stakeholders.
Ensure adherence to company policies, procedures, and global regulatory standards.
Oversee manufacturing quality control, raw material and finished product release, process validations, facility inspections, and shipping compliance.
Lead internal audits and host external inspections by regulatory agencies and customers.
Manage non-conformances (NCRs), CAPAs, and complaint investigations.
Maintain global product registrations, clearances, and technical documentation.
Monitor and interpret international laws, regulations, and standards affecting the business.
Coordinate post-market surveillance, vigilance, and recall activities.
Liaise with regulatory agencies such as FDA, Notified Bodies, and Health Canada.
Develop, implement, and maintain policies, procedures, and records to ensure traceability and compliance.
Lead document control processes, including preparation, auditing, training, and enforcement.
Collaborate with Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance.
Support international partners with documentation for product registration.
Work closely with clinical teams to generate PMS, CER, PSUR, and PMCF reports.
Lead departmental planning including staffing, budgeting, and resource allocation.
Provide training to department staff and other teams on quality and regulatory procedures.
Lead and manage the Quality & Regulatory team to ensure departmental effectiveness and alignment with company goals.
Oversee hiring, performance evaluations, training, and professional development.
Foster a culture of accountability, continuous improvement, and regulatory excellence.
Collaborate with advanced leadership and department heads to ensure consistent implementation of quality systems.
Essential Skills
Medical device quality assurance
FDA regulatory affairs
Process and equipment validation
Documentation control
Quality Control
ISO 9001 / ISO 13485
Solid understanding of scientific and engineering principles
Problem-solving and analytical skills
Excellent communication and interpersonal abilities
Proficiency in English
Additional Skills & Qualifications
Bachelor’s degree in Science or Engineering required
Advanced degrees (MS, MBA) preferred
Minimum of 8 years in quality and regulatory leadership roles within the medical device industry
Proficiency in additional languages is a plus
In-depth knowledge of FDA QSR, cGMP, 510(k), PMA
Knowledge of EU MDR, MDD, CE Marking, Technical Files
Familiarity with MDSAP, Health Canada regulations, and IMDRF frameworks
Understanding of ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility)
Experience with Design Control and Document Control systems
Familiarity with regulatory bodies and standards (FDA, ISO, USP, ASTM, OSHA, EPA)
Membership in professional organizations (ASQ, RAPS) and relevant certifications
Work Environment
The work environment includes collaboration with various departments such as Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance. The role involves interacting with regulatory bodies and external stakeholders, and it may require international travel. The department encourages a culture of accountability and continuous improvement, ensuring adherence to global standards and regulations.
Pay and Benefits
The pay range for this position is $60.00 - $85.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Fort Worth,TX.
Application Deadline
This position is anticipated to close on Aug 19, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Job Description
The Head of Quality & Regulatory Affairs is responsible for leading and managing all aspects of quality assurance, regulatory compliance, validation, and document control. This role ensures that products meet the highest standards of quality and safety while maintaining compliance with global regulatory requirements.
Responsibilities
Ensure the quality and compliance of all products and manufacturing processes.
Provide guidance and support to internal departments across the organization.
Represent the company in interactions with regulatory bodies and external stakeholders.
Ensure adherence to company policies, procedures, and global regulatory standards.
Oversee manufacturing quality control, raw material and finished product release, process validations, facility inspections, and shipping compliance.
Lead internal audits and host external inspections by regulatory agencies and customers.
Manage non-conformances (NCRs), CAPAs, and complaint investigations.
Maintain global product registrations, clearances, and technical documentation.
Monitor and interpret international laws, regulations, and standards affecting the business.
Coordinate post-market surveillance, vigilance, and recall activities.
Liaise with regulatory agencies such as FDA, Notified Bodies, and Health Canada.
Develop, implement, and maintain policies, procedures, and records to ensure traceability and compliance.
Lead document control processes, including preparation, auditing, training, and enforcement.
Collaborate with Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance.
Support international partners with documentation for product registration.
Work closely with clinical teams to generate PMS, CER, PSUR, and PMCF reports.
Lead departmental planning including staffing, budgeting, and resource allocation.
Provide training to department staff and other teams on quality and regulatory procedures.
Lead and manage the Quality & Regulatory team to ensure departmental effectiveness and alignment with company goals.
Oversee hiring, performance evaluations, training, and professional development.
Foster a culture of accountability, continuous improvement, and regulatory excellence.
Collaborate with advanced leadership and department heads to ensure consistent implementation of quality systems.
Essential Skills
Medical device quality assurance
FDA regulatory affairs
Process and equipment validation
Documentation control
Quality Control
ISO 9001 / ISO 13485
Solid understanding of scientific and engineering principles
Problem-solving and analytical skills
Excellent communication and interpersonal abilities
Proficiency in English
Additional Skills & Qualifications
Bachelor’s degree in Science or Engineering required
Advanced degrees (MS, MBA) preferred
Minimum of 8 years in quality and regulatory leadership roles within the medical device industry
Proficiency in additional languages is a plus
In-depth knowledge of FDA QSR, cGMP, 510(k), PMA
Knowledge of EU MDR, MDD, CE Marking, Technical Files
Familiarity with MDSAP, Health Canada regulations, and IMDRF frameworks
Understanding of ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility)
Experience with Design Control and Document Control systems
Familiarity with regulatory bodies and standards (FDA, ISO, USP, ASTM, OSHA, EPA)
Membership in professional organizations (ASQ, RAPS) and relevant certifications
Work Environment
The work environment includes collaboration with various departments such as Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance. The role involves interacting with regulatory bodies and external stakeholders, and it may require international travel. The department encourages a culture of accountability and continuous improvement, ensuring adherence to global standards and regulations.
Pay and Benefits
The pay range for this position is $60.00 - $85.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Fort Worth,TX.
Application Deadline
This position is anticipated to close on Aug 19, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.