Regulatory Affairs (RA) Global Director
Departments: Regulatory Affairs
Reports to: Vice President, Quality Assurance & Regulatory Affairs
FLSA Status: Exempt
Reporting to the VP, Quality Assurance & Regulatory Affairs, the RA Global Director will apply expert knowledge to help develop the regulatory strategy for Apyx® Medical’s product development pipeline and will also direct the day-to-day regulatory activities for all Apyx Medical sites. This position, as a key member of the leadership team, requires both strategic and operational capabilities in developing formal regulatory operational processes and procedures, working with development teams to manage submission strategies for all projects/submissions, and develop an effective method to track regulatory commitments, deliverables and submission content. Responsible for creating functional strategies and specific objectives for regulatory affairs, developing budgets/policies/procedures to support the functional infrastructure, coordinating with various internal departments to assure operational and procedural compliance with state, federal and international regulations. Works closely with other functions of the company, including other members of the regulatory affairs team, quality assurance, research & development, clinical affairs, medical affairs, sales & marketing, operations and finance.
ESSENTIAL DUTIES AND RESPONSIBILITIES (this position may perform other activities as necessary to maintain customer satisfaction and regulatory compliance):
- Regulatory Operations Responsibilities – Develop and implement systems, procedures and practices to sustain the regulatory operations in line with the required industry standards, certification requirements, regulatory requirements and business requirements across the organization. Operationalize tribal knowledge of regulatory processes by developing reproducible processes and documented procedures to support these processes throughout all areas of the RA operations. Develop procedures to ensure regulatory compliance. Lead and champion operational process improvement for regulatory submissions and document tracking. Identify and support regulatory operations improvement initiatives. Procure and oversee outside vendors and consultants as required. Embed a culture of continuous improvement throughout the company. Lead the team to achieve business targets for customers and business goals. Develop robust processes to ensure that regulatory documentation is stored and archived in a timely fashion and in a manner that facilitates recovery. Oversee the review of product labeling and marketing materials to ensure compliance with regulatory requirements. Manage resources to support proper labeling of product to include UDI and GUDID requirements.
- Regulatory Submissions, Registrations & Licenses Responsibilities – Ensure that Regulatory processes (510k submissions; foreign government submissions, registrations and renewals) are effective at meeting business objectives. Direct the regulatory submission and clearances processes to assist in determining the regulatory path to market for the US (Q-Sub, 510K, IDE, De Novo) and prepare and/or review submission documentation for all new products in support of the business plan. Provide leadership in determining the regulatory requirements for modifications to existing products and guide the RA team in preparing all necessary submission documentation. Direct the process for regulatory submissions in other countries/regions (EU, Latin America, Canada, China, Japan, Middle East, etc.) in support of the business plan. Oversee the process for on time maintenance of product registrations and listings for the US, state or local licenses and registrations in all other countries in support of the business plan. Develop and maintain tracking tools to manage regulatory deliverables, including health authority commitments, submission content, amendment and approval dates, etc., for all submissions in all countries where Apyx Medical is conducting clinical trials; Proactively provide status updates for outstanding and planned submissions. Direct the regulatory process for products requiring governmental approval by ensuring that all necessary applications are filed and maintained within established timelines for all Apyx Medical sites. Serve as the liaison with FDA and other global regulatory agencies with responsibility for oversight of global regulatory submissions.
- Regulatory Leadership – As the leader of the Regulatory team, ensure all regulatory elements are implemented, compliant, effective, and efficient to meet the current and future needs of the Company sites and facilities. Function as a business partner to assist the VP QA/RA in the development of regulatory strategies to meet business needs. Exemplify Apyx Medical’s expectations of leaders.
- Serve as the organization’s technical expert for Pre-Market Regulatory Affairs during internal and external audits. Collaborate cross-functionally to update processes to be compliant with new regulations (MDSAP, EU MDR, ISO 13585, CE Mark) while meeting business needs. Communicate issues related to the regulatory changes or regulatory risks to management as needed. Provide mentoring and training for all associates on regulatory requirements. Promote and ensure companywide regulatory compliance with all applicable national and international standards and regulations.
- Contribute to the development of regulatory strategies, implement these strategies and manage those systems and programs in order to meet corporate goals and objectives. Set departmental objectives and service metrics for RA; Generate reports and communicate findings to management. Facilitate achievement of established department objectives. Coordinate department planning to ensure that the Regulatory department functions optimally and within the budget.
- Communicate the vision of Apyx Medical’s corporate philosophy to all direct reports and use every opportunity available to communicate a vision of cooperation, innovation, and excellence. Maintain RA staff by recruiting, orienting, and training employees and maintain staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results. Hire and manage Apyx Medical’s team of Regulatory professionals. Supervise and direct the work of Regulatory Staff:
- Develop a sense of urgency when key deliverables are jeopardized;
- Facilitate problem solving and meetings to address obstacles;
- Rely on core team members when faced with critical decisions; Hold core team members accountable to program commitments;
- Proactively manage risks and employ strategies to address;
- Actively work to promote team building and morale within the department; Foster teamwork; strive to maintain an environment of openness and trust.
- Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing, or record keeping and ensure that they are communicated through company policies and procedures. Work with Regulators to resolve misunderstandings and seek clarity on the application of various laws and regulations. Triage complex regulatory issues that are escalated by staff. Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as required.
- Expert knowledge and understanding of recognized standards, relevant guidance documents, new regulations. Maintain a good understanding of the current and updated regulatory framework, including regional trends, for various types of applications and procedures across all regions. Maintain a good understanding of the various types of applications and procedures for medical devices and cosmetic medical devices in all regions. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Apyx products. Establish and maintain a professional and credible image with key physicians, consultants, vendors, and co-workers.
- Regulatory Company-wide Support– Participate in the short- and long-range planning of new product opportunities. Oversee the development and maintenance of Technical Files and product listings. Support new product development the Regulatory resources in support of DHF documentation review and design review meetings. Support Clinical Affairs by providing guidance on IDE and post-market clinical studies. Write and/or review regulatory documentation and serve as a resource for other document owners regarding regulatory content. Work with Marketing to develop claims matrices for promotion and advertising claims approved by the VP QA/RA. Develop and maintain marketing materials review procedures and conduct required training on promotion of products.
The RA Global Director will have direct supervision of all employees in the Pre-Market Regulatory Affairs department (see Organizational Chart).
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND EXPERIENCE
A Bachelor’s or Master’s degree in scientific, health care, or related field or equivalent. Minimum of (7+) years in Regulatory Affairs leadership roles including direct, industry-related regulatory experience within the medical device industry. Must have demonstrated experience/knowledge of Regulatory Affairs, Quality Systems, MDD (EU-MDR), ISO, MDSAP requirements and medical device industry regulations. 15 years’ experience in a regulated medical manufacturing environment with Senior Leadership experience is required.
Position will be based in the Clearwater, FL Corporate Headquarters. Travel up to 10% may be required.
EMPLOYMENT WITH APYX MEDICAL
All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole and absolute discretion.
Join the team where we offer a rewarding work experience, compensation and benefits package. Salary is commensurate with professional experience. For immediate consideration, please forward your resume, along with salary requirements, to: Asanka Abeyratne, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760-4004 or e-mail HR@apyxmedical.com.
APPLYING FOR EMPLOYMENT
If you are interested in becoming a member of the Apyx Medical team, you may download our Employment Application PDF, fill it out, and send it along with your resume using any of the following methods:
EMAIL OUR HUMAN
MAIL A HARD COPY
c/o Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004