Sr. Regulatory Affairs Specialist Responsibilities Include: - Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review. - Provide technical review of data or reports that will be incorporated into regulatory submissions. - Analyze validation test data to determine whether systems or processes have met validation criteria. - Study product characteristics or customer requirements and confer with management to determine validation objectives and standards. - Identify deviations from established product or process standards and provide recommendations for resolving deviations. - Develop validation master plans, process flow diagrams, test cases, and standard operating procedures. - Create, populate, and maintain the database for tracking validation activities, test results, and validation systems. - Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval. - Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements. - Prepare additional information or responses as requested by regulatory agencies. - Research and interpret regulatory rules or rule changes and ensure they are communicated through company procedures. - Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. - Recommend changes to company procedures in response to changes in regulations or standards. - Advise team members on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. - Responsible for FDA submissions (510k) with the team, managing that process. Hard Skills + 8-10 Years of Regulatory Affairs Experience + +5 Years of FDA & EU Experience + MDD to MDR Transition Experience + PMA, 510k Submissions Experience Work Site This is a fully on-site position in Saint Paul, Minnesota. Work Environment This person is required to come on-site 5 days per week. There is flexibility in the scheduled hours. 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.