Manager, Regulatory Affairs

CountryUnited StatesShift1stAbout the Position Introduction WerfenWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.Overview Job SummaryAutoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and indirect reports. Activities are performed in accordance with standard operating procedures (SOPs), Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies.Responsibilities Key AccountabilitiesTeamwork : Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects.New Product Development Support : Assist the Regulatory Affairs team in developing regulatory plans and oversee implementation for introducing new products in various geographies. Oversee and assist the Regulatory Affairs team in preparing and submitting regulatory submissions.On-Market Support (Sustaining) : Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations.Regulatory Intelligence : Oversee and perform ongoing surveillance of new and revised regulatory requirements globally.Department Management : Establish and monitor priorities and goals for the Regulatory Affairs team concerning new product development support and sustaining of on-market products.Team Management : Responsible for overall performance of department operations, personnel and budget.Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Qualifications Education : Bachelor’s degree in bioengineering / biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.Regulatory Affairs Certification preferred.Experience : Minimum 8 years of experience in Regulatory Affairs, with at least 5 years in IVD Regulatory Affairs.Minimum 5 years of experience in managing regulatory professionals.Demonstrated success in obtaining regulatory approvals in major geographies.Skills & Capabilities : Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU, Canada, and Australia.Strong knowledge of IVD product development process.Strong skills in verbal and written communication including scientific writing and presentation.Travel Requirements : Approximately Other Duties and Acknowledgement : The above statements are intended to describe the general nature and level of work being performed by the incumbent. This job description does not constitute or contain a contract or employment promise of any kind. Werfen is an Equal Opportunity employer and is committed to a diverse workplace.#J-18808-Ljbffr