Director, Regulatory Affairs

Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

The Regulatory Affairs Director for Autoimmunity will build and lead a growing Regulatory Affairs team by recruiting, managing, coaching, and developing the team to ensure skills are aligned with a high performing organization. This position will direct the Regulatory team in supporting products (instrumentation, hardware, software, and reagents) over their lifecycle from new product development, market authorization documentation, labeling review, design changes, post market activities including field actions, reportable events, and surveillance. The Director will confirm information and data in support of marketing authorizations, regulatory reports, and post market documentation is complete and accurate to state-of-the-art guidances, standards, and regulations. The position will ensure proactive regulatory intelligence to develop regulatory strategies and implementation plans in collaboration with project teams, affiliates, and distributors to implement regulatory affairs strategies and projects.

Responsibilities

Key Accountabilities

• Design Control: Guide cross-functional teams in defining regulatory requirements, identifying regulatory risks then generating, deploying, and implementing corresponding regulatory strategies. Confirm appropriateness of internal evidence of safety and efficacy for acceptability in licensing applications, submissions, and registrations for market authorization in indicated geographies.
• Marketing Authorizations: Provide guidance with input from regulatory bodies and distributing partners on most effective regulatory path for achieving marketing authorization. Lead team to schedule milestones, generate supporting documentation, and provide deliverables for assigned global regulatory applications, registration, licensing, reporting. submissions declarations, attestations, certifications, design dossiers, technical documentation, export certificates, and renewals according to governing rules and regulations of the affected geographies. Oversee the final review of market applications to ensure compliance to regulatory agency standards and requirements for submissions. Represent company in interactions and communications with regulatory authorities. Coordinate with internal personnel to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies.
• On Market Support: Manage team in creation, changes to, review, assessment and maintenance of design changes, product labeling, advertising and promotional materials, design dossiers, technical documentation, regulatory agencies communications, post-market reports, health hazard evaluation, risk-benefit reports, reportable event assessments and filings, and Field Action/FSCA assessments and filings, license application and renewals, and laser reports while ensuring records organized maintained in central repository. Represent company in interactions and communications with regulatory authorities.
• Regulatory Intelligence: Actively participate in trade and professional organizations to maintain current knowledge of applicable regulatory requirements and scientific breakthroughs in the marketed geographies and technologies. Monitor, analyze and develop strategies for new and emerging regulations, guidances, and standards in marketed geographies. Deploy and coordinate plans for establishing and maintaining compliance. Communicate impact on the business or portfolio to senior management.
• Department Management: Educate and broaden the regulatory knowledge of the department and understanding of other function