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At Gentherm, we say, “It’s about the person.” We’re with you on a cold winter day when you turn on your heated seat and steering wheel or helping manage patient body temperature in the operating room, recovering room or intensive care units. We take a human approach with everything we do.

 

As the global market leader of innovative thermal management and pneumatic comfort technologies for the automotive industry we embrace the opportunity to create and deliver extraordinary solutions  that make meaningful differences in everyday life. We do this by improving health, wellness, comfort and energy efficiency.

 

 

We embrace an entrepreneurial spirit and combine that with our global leadership to deliver results. Working at Gentherm provides you the opportunity to not only shape the future of the automotive and medical industries, but also influence your career throughout the company. You will be engaged, challenged and inspired by our team to deliver leading thermal technologies that positively impact lives around the world.

IMPACT and OPPORTUNITY:

We are looking for a detail-oriented and customer-focused Senior Manager, Regulatory Affairs who is responsible for assisting the Quality Assurance Regulatory Affairs (QARA) team with regulatory filings as necessary to market Gentherm products. This position requires a strong understanding of medical devices, their use and the product lifecycle as well as an understanding of the regulatory submission process. This role is 100% remote and can live anywhere in the continental US. Quarterly travel will be required to our Headquarters in Cincinnati, Ohio and/or as business needs dictate.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

  • Prepares complex submissions and/or presentations to regulatory agencies and for any related communications, including but not limited to, U.S FDA, Health Canada, Japan, EU, Brazil, and Australia.
  • Responsible for the compliance and execution of Field Corrective Actions and Country registrations.
  • Creates regulatory strategy inclusive of international registration.
  • Provides support to the following QMS processes:
    • New Product Development
    • Marketing and labeling Reviews
    • Risk management
    • Technical Documentation for EU MDR
  • Serves as representative of the regulatory affairs function to improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.
  • Responsible for regulatory support for assigned development/continuous improvement projects.
  • Serves as a liaison between regulatory bodies and necessary departments of the company.
  • Performs other related duties and responsibilities, as assigned.

MINIMUM QUALIFICATIONS:

  • Bachelor’s Degree or equivalent work experience.
  • A minimum of seven (7) years of quality or regulatory affairs/compliance experience, with 5 years in Regulatory Affairs, preferably within the medical device industry, or a medical/healthcare related field (equivalent combination of education, experience, and training considered

PREFERRED QUALIFICATIONS:

  • RAC Certification
  • Strong knowledge of Post-market Surveillance/Vigilance Regulations and Requirements
  • Ability to coordinate and support technical and scientific regulatory activities
  • Ability to conduct analysis of data, organize information, and produce reports based on provided instruction.

COMPETENCIES:

  • Deliver Results
    • Understand the mission and output of your team; set SMART objectives and deliver
  • Drive Change
    • Focus on agility and commitment to continuous improvement; Understand and act on internal and external drivers of change
  • Build Capability
    • Foster a culture of learning and development; Support individual growth through continuous feedback to achieve personal and professional goals
  • Cultivate Innovation
    • Openly embrace, create, implement and support new and innovative ideas, processes and technology that deliver business results

Gentherm is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.

Job Req ID:  8727
Country/Region:  US
Published:  Jan 11, 2023


Nearest Major Market: Cincinnati

Job Segment: Medical Device, Regulatory Affairs, Compliance, ICU, Risk Management, Healthcare, Legal, Finance