Director of Regulatory Affairs

Posted Jun 17, 2022 Ann Arbor, Michigan

Categories

Inquire Now

Expires Jul 17, 2022

Description

Position Description

  • Develop and implement global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products.
  • Lead submissions, communications, and meetings with Regulatory Authorities.
  • Support Franchise to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
  • Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
  • Direct solutions for complex topics regarding country specific regulations, guidelines, and precedents.
  • Develop Regulatory Affairs processes and procedures for the Global organization.
  • Support functions with product issues involving Regulatory Affairs aspects.

Position Requirements

  • The ideal candidate will have 6-10 years of experience in IVD regulatory affairs, including minimum 5 years in a team leadership role, responsible for successful pre-market submissions.
  • Extensive knowledge of regulatory requirements and processes for US, Canada, and EU commercialization of IVD medical devices (RoW knowledge is a plus). RAC preferred.
  • Strong knowledge in IVD medical devices, Instruments and Software
  • Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.

Personal Requirements

  • Excellent verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.
  • Passionate leader, enthusiastic and able to inspire others to drive results while helping members at all sites feel competent, challenged, and supported a strong sense of ethics and a commitment to uncompromising integrity.
  • Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.
  • Strategic thinker, with ability to find novel solutions to complex business challenges.

Benefits

Full Benefit Package including base salary and bonus.

Salary

$175-210k

Company/Organization

Talent Source Inc

http://www.talentsourcestaff.com

Contact

Christina Bowman | Email