MakroCare Hiring Senior Manager – Regulatory Affairs (Medical Devices)

MakroCare Hiring Senior Manager – Regulatory Affairs (Medical Devices)

26 May, 2022

Job Description:

Sr Manager – Regulatory & Technical Development (Medical Devices)

POSITION SUMMARY:

  • The Sr.Manager, Regulatory and Strategic Development, will be responsible for developing and implementing and regulatory strategies for client projects (Role focus will be 50% RA, 25% on RIM/UDI and other time on adhoc med device and diagnostics aspects).
  • The incumbent will be responsible for the strategy and preparation of regulatory and labeling-related projects for the US FDA, EU and ROW regulatory authorities.
  • The position will include client and regulatory authority liaison.
  • The position will include the supervision and management of regulatory professionals and support personnel.

Job Duties and Responsibilities:

  • Create, monitor and maintain timelines for client strategic development, submission management and regulatory affairs programs.
  • Develop and execute on global strategic plans (regulatory and/or quality systems) for the development of client medical device development programs.
  • Act as subject matter expert in certain areas of EU MDR / IVDR
  • Establish and direct cross-functional teams of internal and external personnel to deliver client projects.
  • Support Regulatory Operations / Submission management Automation / IT efforts
  • Provide training for in-house personnel and supervise the assigned Regulatory staff as needed.
  • Participate in meetings with regulatory authorities
  • Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations and communicates to appropriate personnel.
  • Shows an understanding of the changing regulatory environment and the impact on business practices, policies and projects and demonstrates an ability to discuss relevant points in a diverse forum in more general terms.

Supervisory Responsibilities:

  • Directly supervises employees assigned. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Manages applicable portions of established departmental budget, using good judgment to insure that costs are appropriate and reasonable and that any foreseen overages are communicated for transparency.

Other:

  • Ability to perform business travel (local/international), up to 25%
  • All other projects as assigned

Requirements

Minimum of 8 or 8+ years of experience in Medical Devices (IVD) Regulatory Affairs.

Apply through this Link

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