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Regulatory Affairs Director

Company: Orthofix US LLC
Location: Lewisville
Posted on: November 14, 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 Director

How you'll make a difference?

The Director of Regulatory Affairs leads a team of Regulatory Affairs professionals and is responsible for managing the company's regulatory affairs program by providing expertise to ensure regulatory compliance in all aspects of product development. 510(k) and PMA submissions for the Spine business will be the original focus of responsibility. The Director of Regulatory Affairs is a key partner to the Research & Development, Regulatory 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.

  • Maintain oversight over all regulatory and design quality operations to assure full compliance with applicable laws, regulations and policies.
  • Maintain oversight of domestic and international regulatory strategies for new and modified devices by interfacing with physicians, consultants, internal team members, suppliers and regulatory agencies to ensure expeditious commercial clearances for products.
  • Oversee product and manufacturing changes for potential impact on future and current applications.
  • Assure consistency and quality of submissions, through technical guidance to staff during the course of strategy formulation and submission formulation.
  • Establish departmental priorities and implement through direct supervision of staff, ensuring timely completion of activities in support of company goals.
  • Advise management group of prevailing and evolving FDA and EU regulatory requirements and environment
  • Foster employee career development, and actively participate in trade and professional organizations
  • Owns and drives deliverables through design assurance staff related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives.
  • Develops and implements quality strategies for new product development to attain quality goals.

    What skills you'll need?
    • 10-15 Years of Experience in:
    • Regulatory Affairs in medical device industry and related areas, e.g. R&D &/or Manufacturing
    • Quality Assurance and/or Quality Engineering, including Quality systems, standards, metrics, and tools desirable
    • Canadian Medical Device Regulations (CMDR); EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation, ISO 13485, and ISO 14971 a plus.
    • BS or BA degree, experience with medical devices, Quality System Regulations, ISO 9001 / ISO 13485, CE marking of devices, and quality assurance

      What supervisory responsibilities will you have?
      • Provides guidance and training to staff, assists subordinates in attaining career goals, to include motivating individuals in achieve results.
      • Recruits and maintains a high qualified staff and foster employee career development, and actively participate in trade and professional organizations.
      • Must foster collaboration with cross functional teams

        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, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 50 lbs.
        • Eyesight and hearing must be correctable to standard level.

          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 Director, Executive , Lewisville, Texas

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