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Regulatory Affairs Program Manager

Company: Orthofix US LLC
Location: Lewisville
Posted on: November 19, 2021

Job Description:

Why Orthofix?

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun! As an Orthofix employee, you will become an integral part of our culture by continually demonstrating the highest level of integrity and our beliefs while making an impact to our vision "To be a highly respected global orthopedic and spine company that delivers exceptional value to our patients, customers, team members, partners and shareholders."

Regulatory Affairs Program Manager

How you will make a difference?

The Regulatory Affairs Program Manager is responsible for managing U.S. and global regulatory pre-market submissions and other pre-market filings to acquire and maintain appropriate commercial distribution clearances for specific Orthofix product families / technologies. The Regulatory Affairs Program Manager is a key partner to the Research & Development and Marketing teams in achieving new product development and commercialization.

What will be your duties and responsibilities?

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

  • Prepare and maintain domestic product submissions including FDA 510(k), PMAs, and PMA annual reports
  • Prepare and maintain global product submissions including international registrations and license applications
  • Prepare and maintain Technical Documentation to support product CE-marking
  • Develop regulatory strategies for new products.
  • Provide regulatory affairs support to project design teams
  • Review and approve product labeling
  • Review design and/or process changes and assess regulatory implication relative to the change
  • Provide regulatory support for product and quality system related changes
  • Provide regulatory affairs support during FDA inspections and Notified Body audits
  • Provide regulatory affairs guidance to other Orthofix departments, as necessary
  • Provide support for the company's transition from EU MDD to EU MDR
  • Help drive process and compliance improvements activities

    What skills and experience will you need?
    • Bachelor's degree (science or technical preferred)
    • 10+ years of experience in Regulatory Affairs, specifically in the medical device industry
    • Experience with implantable orthopedic devices.
    • Demonstrated knowledge of FDA QSR, ISO 13485, EU MDD, EU MDR, CMDR and global submission requirements
    • Strong attention to detail and the ability to multitask
    • Excellent oral and written communication skills
    • Ability to prioritize, conduct team meetings, and meet project deadlines
    • Public speaking proficiency
    • Willing to mentor others

      What skills would be helpful?
      • Regulatory Affairs Certification (RAC)
      • Experience with electrical medical devices and associated IEC standards

        What supervisory responsibilities will you have?


        What will the physical demands and work conditions be like?

        The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
        • Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.
        • Eyesight and hearing must be correctable to standard level.
        • Travel required up to 10%, therefore must be able to utilize airplane, taxi, car etc.

          Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Keywords: Orthofix US LLC, Lewisville , Regulatory Affairs Program Manager, Executive , Lewisville, Texas

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