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Sr Director, Regulatory Affairs

San DiegoHologic

Position Summary:
This position has primary management responsibility directly or through lower management levels for the diagnostic division global regulatory affairs department.  Works with regulatory agencies to obtain timely approvals of all products. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements.

Summary of Job Responsibilities
  • Oversee global regulatory compliance of currently approved products.
  • Coordinate and participate in interactions with regulatory authorities.
  • Oversee and coordinate regulatory submissions to domestic and international regulatory bodies.
  • Oversee release of product to global supply chain.
  •  Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback.
  • Responsible for working with regulatory staff to ensure orderly and timely completion of project assignments.
  • Collaborate with cross functional team members to determine optimum global product commercialization strategies.
  • Work independently, directly and effectively with cross-functional disciplines (e.g., research & development, clinical, quality, operations, marketing) to accomplish assigned strategic and operational responsibilities.
  • Guide staff in the interpretation and application of regulations for creating regulatory strategies for domestic and international markets.
  • Review and approve regulatory documentation as required.
  • Review and approve clinical protocols as required.
  • Assess manufacturing process, product design, and labelling changes for regulatory reporting impact.
  • Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry  trends. Disseminates information as directed by management and ensures staff is trained on changes affecting regulatory submissions.
  • Lead product submission meetings with regulatory agencies.
  • Develop and maintain department budget.
  • Oversee review of product labeling and promotional literature for accuracy, consistency and regulatory compliance in accordance with corporate procedures.
  • Participate in, or lead product field actions as required.
  • Represent the Regulatory Affairs function during on-site audits by external parties.
  • Oversee the creation and maintenance of internal regulatory policies and procedures as required.
  • Assist in evaluating and approving RA operating needs and develop specific goals and objectives.
  • Evaluate and recommend organization training programs.
  • Assist VP in establishing long-range organizational goals and strategies.
  • Ensure implementation of good business practices.
  • Hires and retains a diverse and highly qualified Regulatory team. Provides ongoing performance feedback and coaching to maintain high level of performance and engagement.
  • Other duties as assigned.

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