Manager, Regulatory Affairs (IVD)

We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. This position is focused on in vitro diagnostic systems including assay, software and hardware. The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.

Job Summary

• The primary responsibility of the Manager of Regulatory Affairs is to submit global regulatory submissions for new commercial products, assess product or process changes, and participate in quality related activities (complaints, nonconformances, field actions, etc.) focused on in vitro diagnostic systems, including software and hardware; to meet project timelines and / or regulatory obligations. 
• Work cross functionally to assess regulatory impact of fielded product issues with an emphasis on software or hardware. This individual will have the necessary skills and experience to assess potential global field actions, complaints, Post Market Surveillance activities and nonconforming events to comply with applicable regulations.  This includes assessing software and hardware changes required for PMA products to meet project timelines and / or regulatory obligations. Includes working with both internal Hologic employees as well as external distributors and affiliates to accomplish the goals in a timely manner.  
• Responsible for implementing policies and procedures to accomplish assignments and resolve a broad range of issues. Responsible for ensuring employee compliance with such policies, practices and procedures and for encouraging continuous process improvement. Ensures that the quality of services meets internal and external customer requirements.

Essential Duties and Responsibilities

• Manage staff in implementing regulatory strategy and preparing domestic and international regulatory submissions, focused on software and hardware for in vitro diagnostic systems, to meet organizational goals.
• Participates in product development core teams as regulatory representative, as assigned.
• Provides guidance on regulatory requirements and strategies for issues related product in the field and products still under Hologic’s control with a focus on hardware and software for the IVDR systems.  Responsibilities include relevant tasks within the following workflows:
  • Complaints associated with multiple manufacturing sites and respective their respective QMS
  • Vigilance and MDR reporting, as needed
  • Post Market Surveillance 
  • Nonconforming product impact assessments
  • Corrective and Field actions
• Manages the preparation of submissions for products to regulatory agencies, and interfaces with agencies to obtain timely approval.
• Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
• Maintains advanced working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues, primarily focused on software, including cybersecurity, or hardware that may impact company operations and decision-making; communicates such knowledge to all internal stakeholders.
• Consults with and provides advice to senior management on strategies and plans for regulatory product approvals and on-market regulatory strategies.
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re- occurrence.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Encourages continuous process or procedural improvement. 

Required Qualifications and Experience

• Bachelor's Degree required in the life sciences or biomedical engineering with a minimum of 8-10 years direct experience in Regulatory Affairs within the IVD or medical device industries.  
• Master’s Degree in biomedical engineering and/or RAC preferred with a minimum of 5-8 years direct experience in Regulatory Affairs with