Texas Staffing
Quality/Regulatory Manager
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 include: Ensuring the quality and compliance of all products and manufacturing processes. Providing guidance and support to internal departments across the organization. Representing the company in interactions with regulatory bodies and external stakeholders. Ensuring adherence to company policies, procedures, and global regulatory standards. Overseeing manufacturing quality control, raw material and finished product release, process validations, facility inspections, and shipping compliance. Leading internal audits and hosting external inspections by regulatory agencies and customers. Managing non-conformances (NCRs), CAPAs, and complaint investigations. Maintaining global product registrations, clearances, and technical documentation. Monitoring and interpreting international laws, regulations, and standards affecting the business. Coordinating post-market surveillance, vigilance, and recall activities. Liaise with regulatory agencies such as FDA, Notified Bodies, and Health Canada. Developing, implementing, and maintaining policies, procedures, and records to ensure traceability and compliance. Leading document control processes, including preparation, auditing, training, and enforcement. Collaborating with Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance. Supporting international partners with documentation for product registration. Working closely with clinical teams to generate PMS, CER, PSUR, and PMCF reports. Leading departmental planning including staffing, budgeting, and resource allocation. Providing training to department staff and other teams on quality and regulatory procedures. Leading and managing the Quality & Regulatory team to ensure departmental effectiveness and alignment with company goals. Overseeing hiring, performance evaluations, training, and professional development. Fostering a culture of accountability, continuous improvement, and regulatory excellence. Collaborating 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 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 for other accommodation options.
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 include: Ensuring the quality and compliance of all products and manufacturing processes. Providing guidance and support to internal departments across the organization. Representing the company in interactions with regulatory bodies and external stakeholders. Ensuring adherence to company policies, procedures, and global regulatory standards. Overseeing manufacturing quality control, raw material and finished product release, process validations, facility inspections, and shipping compliance. Leading internal audits and hosting external inspections by regulatory agencies and customers. Managing non-conformances (NCRs), CAPAs, and complaint investigations. Maintaining global product registrations, clearances, and technical documentation. Monitoring and interpreting international laws, regulations, and standards affecting the business. Coordinating post-market surveillance, vigilance, and recall activities. Liaise with regulatory agencies such as FDA, Notified Bodies, and Health Canada. Developing, implementing, and maintaining policies, procedures, and records to ensure traceability and compliance. Leading document control processes, including preparation, auditing, training, and enforcement. Collaborating with Manufacturing, Distribution, R&D, Engineering, Clinical, Marketing, Sales, and Finance. Supporting international partners with documentation for product registration. Working closely with clinical teams to generate PMS, CER, PSUR, and PMCF reports. Leading departmental planning including staffing, budgeting, and resource allocation. Providing training to department staff and other teams on quality and regulatory procedures. Leading and managing the Quality & Regulatory team to ensure departmental effectiveness and alignment with company goals. Overseeing hiring, performance evaluations, training, and professional development. Fostering a culture of accountability, continuous improvement, and regulatory excellence. Collaborating 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 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 for other accommodation options.