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Regulatory Specialist

Job in Cincinnati - Hamilton County - OH Ohio - USA , 45201
Company: Gentherm Inc
Full Time position
Listed on 2021-04-03
Job specializations:
  • Pharmaceutical
    Pharmaceutical QA
Job Description & How to Apply Below
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.

IMPACT and OPPORTUNITY

We are looking for a detail-oriented and customer-focused Regulatory Specialist leads a team of two documentation specialists and is responsible for assisting the Quality Assurance Regulatory Affairs (QARA) team with regulatory filings as necessary to market Gentherm products. This position requires an intermediate understanding of medical devices, their use and the product lifecycle as well as an understanding of the regulatory submission process.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

* Performs assigned duties to support the Quality/Regulatory department and meet Quality objectives.
* Acts as lead for the European MDR transition.
* Prepares and submits applications and reports to applicable regulatory agencies.
* Responsible for the compliance and execution of the following QMS processes:
* Medical Device Vigilance Reporting
* Document Control including Standards/External Documents
* Recall and/or Notification


* Creates regulatory strategy inclusive of international registration.
* Provides support to the following QMS processes:
* Internal Audit
* Design Control / Engineering Change Control
* Marketing and label Reviews
* Clinical Evaluation Reports


* Responsible for regulatory support for assigned development/continuous improvement projects.
* Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
* Prepares for and facilitating third-party audits as necessary.
* Serves as a liaison between regulatory bodies and necessary departments of the company.
* Maintains a deep understanding of new and existing regulations that impact Gentherm's products and processes.
* Performs other related duties and responsibilities, as assigned.

MINIMUM QUALIFICATIONS

* Bachelor's Degree or equivalent work experience.
* A minimum of five (5) years of quality or regulatory affairs/compliance experience, preferably within the medical device or pharmaceutical industry, or a medical/healthcare related field (equivalent combination of education, experience, and training considered

PREFERRED QUALIFICATIONS

* Strong knowledge of Quality System Regulations
* Strong knowledge of Post-market Surveillance/Vigilance Regulations and Requirements
* Knowledge of Complaint Handling 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.

LEADERSHIP RESPONSIBLITIES

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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

Location:

Cincinnati, OH, US, 45241

Country/Region: US

Published: Mar 31, 2021

Nearest Major Market: Cincinnati

Job Segment: Medical, Regulatory Affairs, Law, Engineer, Pharmaceutical, Healthcare, Legal, Engineering, Science
Position Requirements
Less than 1 Year work experience
 
 
 
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