Director, Regulatory Affairs

Audubon, PA

The Director, Regulatory Affairs is tasked with leading the US and International Regulatory functions. The Director is responsible for growing the business through marketing applications that meet the requirement of the U.S. Food and Drug Administration, European Union and global markets.

The position entails development of regulatory strategy and management of submissions to regulatory agencies, requiring working knowledge of Globus products and of relevant US and international regulations and guidance.  The Director must adhere to FDA 21 CFR, ISO requirements and European medical device regulations in all duties. The ideal candidate's experience should demonstrate dependability, flexibility, critical thinking and maturity.  The individual must be able to travel up to 10-20% of the time as needed.

Primary Responsibilities:

  • Developing and executing strategies for US and international approvals to allow marketing of Globus products around the world
  • Guiding the US Regulatory team in preparing and filing 510(k), IDE, and PMA submissions, FDA reports, responding to questions, and achieving timely clearance/approval for marketing
  • Guiding the International Regulatory team in preparing and filing technical documents for CE marking and international registrations, responding to questions, and achieving timely regulatory approval
  • Developing Regulatory team expertise in terms of project management, writing, testing methods, and product knowledge, and maintain staffing to support current and near-term filings
  • Creating optimized regulatory strategies for Globus regulatory submissions to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement
  • Managing the transition to EU Medical Device Regulations to ensure continued business with existing products and timely new product CE marking.  Develop, implement and manage new SOPs to ensure regulatory compliance with the new regulations
  • Partnering closely with Product Development, Quality, Clinical Affairs, Management and other areas of the organization to ensure timely and strategic submissions
  • Ensuring timely response to International sales staff requests for documentation to support local registrations where appropriate
  • Ensuring appropriate review of Document Change Orders including regulatory pathway determinations, for all new and revised products, under departmental guidelines
  • Providing oversight of internal (note-to-file) documentation with engineering rationales for qualifying changes to devices and line extensions
  • Understanding relevant surgical techniques and clinical use of implant/instrument systems
  • Assisting in review of product labeling, marketing materials, research papers, educational and training materials, to ensure compliance with regulations and corporate standards
  • Participating in quarterly Quality Management Review Meetings
  • Providing regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products
  • Assisting in the development of relevant regulatory SOPs and training staff as necessary
  • Ensuring conformance to 21 CFR regulations, ISO requirements, and EU Medical Device Regulations
  • Attending FDA and trade organization meetings as requested
  • Participating in FDA inspections and notified body audits as needed
  • Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
  • Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

Qualifications:

  • Minimum of 8 years of medical industry experience, or equivalent
  • Minimum of 5 years of regulatory management experience within the medical device industry, or equivalent, preferably with orthopedic or spinal devices
  • BS or MS degree in engineering or science-related field, or equivalent
  • Demonstrated experience with US 510(k) clearance, US IDE and PMA approval, EU CE marking of Class II and III devices, and global registrations in international markets including Asia-Pacific, Latin America, and other markets
  • Demonstrated ability to manage and develop team members and leaders
  • Excellent verbal, written and organizational skills
  • Good computer skills
  • Must be detail-oriented

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

JOB CODE: 1002098