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Job Title: Quality/Regulatory ManagerJob DescriptionThe 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.ResponsibilitiesEnsure 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 SkillsMedical device quality assuranceFDA regulatory affairsProcess and equipment validationDocumentation controlQuality ControlISO 9001 / ISO 13485Solid understanding of scientific and engineering principlesProblem-solving and analytical skillsExcellent communication and interpersonal abilitiesProficiency in EnglishAdditional Skills & QualificationsBachelor's degree in Science or Engineering requiredAdvanced degrees (MS, MBA) preferredMinimum of 8 years in quality and regulatory leadership roles within the medical device industryProficiency in additional languages is a plusIn-depth knowledge of FDA QSR, cGMP, 510(k), PMAKnowledge of EU MDR, MDD, CE Marking, Technical FilesFamiliarity with MDSAP, Health Canada regulations, and IMDRF frameworksUnderstanding of ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility)Experience with Design Control and Document Control systemsFamiliarity with regulatory bodies and standards (FDA, ISO, USP, ASTM, OSHA, EPA)Membership in professional organizations (ASQ, RAPS) and relevant certificationsWork EnvironmentThe 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 BenefitsThe 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 TypeThis is a fully onsite position in Fort Worth,TX.Application DeadlineThis 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.