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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 leader in thermal management technologies we embrace the opportunity to create and deliver extraordinary thermal 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.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Provides direction to the Quality and Regulatory departments to manage priorities and evaluate work performance.
  • Manages Gentherm Medical Quality Management System and the interrelationship of quality system processes. Creates, revises, and reviews quality system documentation.
  • Provides leadership for establishing, sustaining, and continuously improving quality assurance across: Management Controls; Design Controls; Corrective & Preventive Actions; Production & Process Controls; Equipment & Facility Controls; Records, Documents & Change Controls; and Material Controls.
  • Conducts regular management reviews and supervises team that performs regular internal quality audits ensuring compliance to standards.
  • Facilitates training programs in conjunction with other Gentherm Medical department leaders to improve product quality and quality control and to promote product reliability and good documentation practices.
  • Working with Gentherm Medical leaders, formulates and maintains quality and regulatory goals complementary to company objectives while maintaining compliance with all applicable standards and regulatory requirements.
  • Leads all regulatory compliance activities including 510(k) clearance, product approvals, complaint handling, Medical Device Reporting, Corrections and Removals, new product development, management reviews, regulatory affairs, and International Product Registration/Approvals.
  • Formulates and implements regulatory affairs policies & procedures to ensure regulatory compliance is maintained.
  • Leads and hosts quality system audits and inspections from third party organizations such as FDA, ISO Registrar, Notified Body, and product safety.

OTHER DUTIES

  • Responsible for Supplier Quality including Supplier auditing, development and Corrective Actions in collaboration with Purchasing.
  • Manages the preparations and submission of regulatory agency applications, reports or correspondence.
  • Ensures regulatory compliance is maintained with distributors and Sales representatives by addressing requirements in their respective contracts including International Registration.
  • Responsible for product risk evaluation, Post Market reporting, and Clinical Assessment/Evaluation by qualified personnel. Designs and implements regulatory training programs to key personnel and all employees where identified in conjunction with department managers.
  • Manages Corrective Action activities as a result of Regulatory Inspections/Audits for timely actions. 
  • Responsible for reporting on Corrective Action Plan and status to Regulatory agencies as well as customers in response to customer and Regulatory Inspections/Audits.
  • Being a Management Representative, leads and hosts quality system audits or inspections from organization such as FDA, Notified Body and customers.
  • Reviews and approves Engineering documents including ECN’s, product and process validations, and manufacturing Q sheets and P-sheets as required.

MINIMUM QUALIFICATIONS

  • Bachelor's degree required, preferred in life sciences, health care, or related discipline.
  • Seven to ten years' experience as a Manager or Director.
  • At least ten years of regulatory compliance/quality systems/regulatory submissions experience in medical devices required.
  • Prior experience with international medical device regulatory requirements and marketing authorization.
  • Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others.

NICE TO KNOW

  • TRAVEL: Up to 25%, domestic and global (When permitted) 
  • LEADERSHIP RESPONSIBILITIES: Team of 12 

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

PHYSICAL DEMANDS/WORK ENVIRONMENT (US)

All positions in our office require interaction with people and technology while either standing or sitting. In order to best service our customers, internal and external, all associates must be able to communicate face-to-face and on the phone with or without reasonable accommodation. Gentherm is committed to compliance with its obligations under all applicable state and federal laws prohibiting employment discrimination. In keeping with this commitment, it attempts to reasonably accommodate applicants and employees in accordance with the requirements of the disability discrimination laws. It also invites individuals with disabilities to participate in a good faith, interactive process to identify reasonable accommodations that can be made without imposing an undue hardship.

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:  7574
Location: 

Cincinnati, OH, US, 45241

Country/Region:  US
Published:  Mar 18, 2021


Nearest Major Market: Cincinnati

Job Segment: Medical, Regulatory Affairs, Manager, Law, Healthcare, Legal, Management, Quality