Director of Regulatory Affairs

Job Description – Director Regulatory Affairs

• Position will be based in Austin, TX
  • Relocation will not be required during COVID pandemic operating time frame
• Leads a local team consisting of RA Manager and 2 RA Specialists
  • Evaluate current processes and improve quality, throughput, efficiency of product registration successes
• Responsible for all RA aspects of an orthopedic implant company (regulatory registrations worldwide, product safety and reporting / actions, regulatory filings, evaluating product change for regulatory impact, etc)
  • Primary point of contact for all global regulatory agencies, as they relate to Surgical products and registrations
  • Coordinate with Clinical leadership to establish appropriate regulatory strategies for new product approvals, expansion opportunities
  • Specific focus in product registration pathways, while regulatory compliance is supported by Corporate / QA
  • $250M+ business growing at 15%+ for the last 8 years
  • Strategy includes expansion internationally
• Needs extensive experience with Class II orthopedic implants in the US and EU
  • Experience in Class III (US) products is also must, with knowledge of the PMA and EU MDR process including applications, supplements, and annual reporting
    • Initial focus will be acquisition and integration of a Class II / III product family
  • Strong leadership skills, but player / coach
    • Will need to dive in and get work done, while also leading the RA team and developing strategy and managing existing talent and identifying needs for a growing business unit

Essential Duties and Responsibilities:

• Provide general direction, tactical objectives, and functional plans for execution of Regulatory Affairs Department
• Develop strategy and key initiatives for DJO Surgical’s business in relation to Regulatory Affairs and product registration pathways globally
• Develop, communicate, and track goals necessary to the success of the Regulatory Affairs Department, as it relates to the success of the Company
• Partner with Sales, Customer Service, R&D, Operations, and Logistics to ensure appropriate compliance and activities for a regulated Medical Device organization
• Develop product registration pathways in the US, Europe, Japan, Australia, and other global regions to meet the needs of the DJO Surgical business and it’s overall strategic plans
• Support product and business acquisitions in relation to Regulatory requirements and product acquisition and transfer
• Primary point of contact for Regulatory agencies globally, as they relate to DJO Surgical products
• Experience and knowledge in FDA Class I, II, and III devices, specifically to current 510(k) and PMA application processes and the associated activities (PMA submissions, PMA annual reports, 510(k) updates)
• Experience in knowledge of global product pathways including EU CE (MDD and MDR), Japanese MHLW, Australian TGA, and others
• Partner closely with Clinical Affairs to ensure proper clinical strategies and execution to support the Regulatory product pathways for both approvals and maintenance
• Responsible for monitoring product safety as well as adverse event assessment and reporting
• Responsible for DJO Surgical Regulatory Affairs Special Processes not otherwise listed.
• Ensures that all policies and strategies at DJO Surgical are in full compliance with all applicable regulatory requirements while still maintaining operational efficiency for the company
• Regularly consult with business leaders to develop corrective action plans and strategies to improve the business processes and results
• Effectively manage change to ensure compliance with regulatory affairs and the changing global regulatory landscape
• Work is accomplished through managers, principles, specialists, and associates
• Provides guidance to subordinates to achieve goals
• Exercises the usual authority of a manager including selection and development of staff, talent acquisition and performance management

Ability to:

• Collaborate, influence and build strong sustainable business relationships with various functions and levels throughout the organization.
• Clearly and concisely communicate orally and in writing to individuals and groups in a compelling manner.
• Interpret and understand regulatory requirements on a global scale, and implement proper process and system changes to meet changes in regulations
• Make decisions using insights, data, and cross functional collaboration inputs.
• Adapt and support the organization through times of change
• Precisely and proficiently conduct business and data analyses and forecasts with data driven recommendations for improvements and advancements.
• Operate and use telephones, computers/laptops and other technological devices/software programs to communicate with other people.

Qualifications:

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's degree in analytic field or equivalent.
• 15+ years relevant regulatory experience - Medical Device
• Previous people management experience, including supervision of leaders
• Proficient in Microsoft Office Suite (Outlook, Excel, Word, and Power Point)
• Oracle experience as an ERP preferred (Inventory, MRP, ASCP)

Preferred Skills

• MBA
• Regulatory Affairs Certification (RAC)