Job Title: Regulatory ManagerJob DescriptionManage and coordinate quality and regulatory functions to determine and maintain compliance with processes and procedures. Provide leadership and direction throughout the plant regarding compliance and contribute to the overall effectiveness and efficiency of the quality system.Manage a variety of departmental functions including managing audits (internal and external), annual regulatory reporting, recall program, regulatory product registrations, facility registrations, medical device document management, internal investigations (Deviations, CAPAs), artwork review, training program, sanitation program, customer complaint program, validation program. Serve as regulatory expert, assuring compliance of all products with regulatory and customer requirements. Advise leadership of all compliance issues and recommendations of corrective action. Keep up to date on regulatory updates and changes impacting the business.Participate in development and approval of standard operating procedures, validations and other activities to support development of production processes. Assure all procedures comply with FDA cGMPs and other regulatory requirements. Maintain compliance programs for FDA and other regulatory requirements. Maintain liaison with federal, state, and local regulatory agencies. Notify executive management of regulatory compliance requirements and deficiencies.Hard Skills
OTC
Regulatory Compliance
Quality System Management
FDA cGMPs
Audit Management
Regulatory Reporting
Product Registrations
Document Management
Internal Investigations
Validation Program
Soft Skills
Leadership
Attention to Detail
Communication
Problem-Solving
Team Collaboration
Job TypeThis is a permanent position.Work SiteThis is a fully on-site position in Jackson, Wisconsin.Work EnvironmentWill work both within the manufacturing area, office, and laboratory as needed.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.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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 process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.