Senior Director, Clinical and Regulatory Affairs

Watertown, Massachusetts, United States | Full-time

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Reporting to the CEO, the Senior Director of Clinical and Regulatory Affairs will lead the strategic direction and operational aspects of clinical development, global regulatory compliance and submissions for Affera’s Class II and III medical devices.

This position will be responsible for developing a strategic clinical and regulatory plan through pivotal IDE trials, developing strong relationships and obtaining regulatory approvals from the FDA and other global regulatory agencies.

Responsibilities

  • Develop strategic direction and priorities for clinical development, working with engineering, quality and operations leadership to define clinical development projects including objectives, work plans, milestones and deliverables.
  • Design and execute pivotal clinical trials in line with Good Clinical Practice, Affera SOPs, FDA guidelines, and ISO standards (as applicable), including prioritizing indications, choosing appropriate populations and endpoints, planning and executing statistical analysis, and identifying risks.
  • Provide overall clinical site management from qualification/start-up to closeout, including training, site initiation, CRF review, protocol and regulatory compliance, device accountability, and visit reports.
  • Develop and implement a regulatory strategy and related activities needed to demonstrate safety and effectiveness and to reach premarket notification and/or approval.
  • Actively support the regulatory submission process, acting as a point of contact for FDA or other regulatory bodies.
  • Ensure regulatory compliance of Affera’s devices with the FDA and other applicable regulatory jurisdictions, identifying and assessing regulatory risks.

Preferred Qualifications and Experience

  • BS or higher in a technical or clinical discipline (engineering, biology/life sciences)
  • 10+ years clinical research experience in a medical device setting.
  • Experience with a Class III medical device strongly preferred.
  • Previous experience in a pivotal IDE trial with a cardiovascular device preferred.
  • Experience with Electronic Data Capture (EDC) systems.
  • Demonstrated experience with major regulatory submissions – PMA, 510(k), etc.
  • Excellent analytical skills required; some formal training in statistics is preferred
  • Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a start-up environment.
  • Ability and willingness to travel.

Perks: 

  • Contribute to an innovative solution that can improve the lives of millions.
  • Learn under the guidance of some of the industry's prominent experts in the field of medical device engineering.
  • Bright, motivated co-workers in a fun and collaborative office environment.
  • Competitive salary, 401k, generous medical coverage to suit your needs.