Director Regulatory Affairs

September 14, 2017 | Lexington, MA (USA) | Quality Assurance and Regulatory Compliance

Scope:

Responsible for directing global Regulatory Affairs activities. Develops and implements strategy for product clearance and approvals of In Vitro Diagnostic Instruments and Reagents. Formulates and recommends regulatory policies and programs. Contributes to the development of departmental budget and the management of this budget. Provides on-going direction and mentorship to regulatory staff. This position may be located in our Lexington, MA or San Diego, CA facilities.

Summary: 

The ideal candidate for this position would have extensive experience managing complex submissions and technical files (instrumentation, software and reagents) for US FDA 510(k) and EU CE mark products in accordance with regulatory requirements. Additionally, the candidate would demonstrate strong leadership skills and experience in managing a department of Regulatory Affairs professionals. Further, the candidate will have extensive experience with the processes and procedures for bringing In Vitro Diagnostic medical product(s) through the design control process from feasibility to launch. This candidate will be responsible to manage activities associated with regulatory approval of in vitro diagnostic medical products and responsible for activities which lead to and maintain domestic and international regulatory approval to market devices or changes that may have regulatory implications. 

Responsibilities: 

  • Develops regulatory strategies and implementation plans, in partnership with the project teams that achieve the Company’s strategic goals. Oversees implementation of all such plans to successful conclusion.
  • Prepares and submits files for global regulatory clearances and approvals, the primary focus is on US, Japan, Europe, Middle East, and Asia.
  • Primary contact with regulatory agencies for global product registrations.
  • Manages FDA submissions, including Pre-Sub meeting planning and follow ups.
  • Provide leadership and direction for currently marketed products, e.g., review engineering changes, labeling, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
  • Manage submission activities for a variety of regulatory approvals including the CE mark, US premarket notifications (510(k)s), export certificates, Rest of World Dossiers, as well as, licenses and device listings.
  • Manages the review and final approval process of all product advertising and labeling to determine compliance with global labeling requirements.
  • Hires and works with external consultants as needed to achieve regulatory aspects of the business goals
  • Manages the International Regulatory submission process, for Rest of World countries. 

Education / Experience:

  • BS/BA degree in Science or related field; MS degree preferred or a focused degree in Regulatory Affairs.
  • 10+ years related regulatory experience
  • In-vitro diagnostic (reagents and instrumentation/software) experience
  • In-depth understanding and experience with FDA, CE and ISO regulatory requirements relative to developing strategic regulatory development plans.
  • Strong understanding and experience with Design Control requirements is required
  • Experienced RA leader to core team(s) for product realization diagnostic projects
  • Knowledge in the process of analytical and clinical trial requirements for successful regulatory approvals, both US and OUS, preferred. 

Skills / Pre-requisites:

  • Ability to communicate with and influence the Executive Team and build effective relationships across all functions of the business.
  • Excellent cross-functional team participation skills.
  • Highly organized and results and goals oriented.
  • Enthusiasm, attention to detail, the ability to meet aggressive deadlines, and ability to work effectively with others in a fast paced, highly-productive environment.
  • Ability to instill the Sekisui core values and serve as positive example to team members and others within the organization.
  • Effective personal communication skills, shares knowledge with excellent training skills.
  • Passionate for both personal and corporate success.

Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted.

Director Regulatory Affairs, San Diego

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