Regulatory Affairs Manager

Regulatory Affairs Manager

My client is a global leader in specialty dental devices and equipment.  They are seeking a Regulatory Affairs Manager to oversee all regulatory activities and manage a team of regulatory specialists.  You will help to establish regulatory processes and procedures while training junior staff members.  It’s an exciting time to join this stable, growing company and help them to get new devices approved globally.

Responsibilities:

  • Manage the process for submitting and maintaining product registrations both domestically and internationally, including FDA 510(k), EPA, UL/CSA and CE.
  • Direct supervision, training, and coaching of three Regulatory Affairs Specialists.
  • Manage the company’s interactions with regulatory agencies, notified bodies and other certification agencies.
  • Ensure that regulatory systems and processes are maintained in compliance with both domestic and international regulatory standards.
  • Stay up to date on the regulatory environment, advise senior management of changes, and take proactive measures to anticipate compliance issues before they arise.
  • Serve as product and process compliance program owner and interpret regulations and develop compliance standards, procedures or programs.
  • Manage the corrective action (CAPA) process. Ensure that CAPAs are investigated and closed in a timely manner. Provide regular reports and metrics to senior management.

Knowledge and Skills:

  • Bachelor of Science degree in a science, mathematics, engineering, or other technology field.
  • 3 – 5 years of experience managing regulatory affairs programs for medical device products in a manufacturing environment.
  • In-depth knowledge of 21CFR 820, ISO13485, and MDD QMS requirements.
  • 1 – 3 years of direct staff management experience along with team-building skills.
  • Strong project management experience required.
  • RAC certification desired and Six Sigma certification is a plus.
  • Must be able to communicate clearly and effectively in both verbal and written form.
  • Must be capable of effectively communicating information to top management, peers, cross-functional team members, and operations staff.

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