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
- 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.
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)
- Regulatory Affairs Certification (RAC)