Regulatory Affairs Manager
Department: Regulatory Affairs
Reports to: Global Director Regulatory Affairs
FLSA Status: Exempt
The Regulatory Affairs Manager assumes responsibility for determining regulatory requirements that affect the company and its products and for the process of preparing submissions to US and international regulatory agencies. The Regulatory Affairs Manager is the liaison for communication with regulatory agencies and regulatory agency inspections The Regulator Affairs Manager will also lead the development, governance and integration of Customer Complaints, Medical Device reporting and Adverse Event Reporting, Corrections and Removals (Recall) and Proactive Post Market Surveillance processes for Apyx Medical products and ensure effective execution into the Quality Management System (QMS). This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. Maintain oversight, tracking, and escalation for Post Market Process and take action to ensure processes are maintained per company policies and industry standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
1. Regulatory Submissions
Responsible for the preparation and submission of all global regulatory documents. This includes product approval submissions and licenses required by Canada, the European Union, and the Unites States. Maintenance of Technical Documentation, Declarations of Conformity, MDD product lists, Clinical Evaluation Reports and Canadian licenses. Review protocols and reports to support regulatory submissions. As required, responds to requests for regulatory information from distributors, other manufacturers, and device users. Maintains regulatory databases and records. Oversee the electronic submission publishing activities conducted by an external vendor for International registrations. Responsible for establishing and maintaining the regulatory submission archive.
2. Regulatory Support
Provide input and guidance to product development teams on regulatory requirements and regulatory strategies. Serve as the Regulatory Affairs representative on program teams and cross-functional sub-teams. Responsible for establishing and maintaining the regulatory submission archive. Provide feedback and execute regulatory filing strategies and submission types. Work with RA Global Director to develop regulatory and compliance operating procedures and policies. Perform regulatory assessment of device modifications. Support the coordination of FDA and regulatory agency meetings to determine regulatory strategies for new products and new clinical applications.
3. International Regulatory Affairs
Determine international regulatory requirements and submit international regulatory registration documents. Preparation of export certificates. Interact with representatives of domestic and international partners and international regulatory authorities to discuss regulatory issues and submission requirements. Keep current with global regulatory trends and emerging requirements.
4. Regulatory Liaison
Liaison with regulatory agencies as a representative of the Regulatory Affairs department. Provide regulatory review of technical reports and protocols, labeling and advertising, and engineering change orders. Participate in regulatory inspections and audits. Ensure proper communication of regulatory strategies and issues to executive management and affected departments. Provide training in regulatory requirements to company personnel. Keep current on changing global regulations, product line and customer needs. Research regulatory issues and providing guidance and advice to colleagues. Actively support CAPA’s as they apply to Regulatory Affairs.
5. Complaint Handling
Leads, conduct and support complaint investigations for Apyx Medical through close collaboration with Research and Development, Manufacturing, Sales and Marketing and other departments; Accountable for accuracy and quality of investigations; Assure that medical device incidents/complaints are documented, reviewed, investigated, trended, and reported in accordance with current procedures. Lead and perform complex investigations, coordinate, and support Failure Investigations and lead projects related to complaint handling to include communication with Physician users, patients, or medical facility personnel. Improve product performance of fielded devices via Customer Defect Tracking and Resolution to improve overall customer experience. Manage the daily activities of the Complaint department to assist in complaint handling and documentation of investigations. Manage Complaint Coordinator(s) to include scheduling of priorities, monitoring status, performance reviews and overall managerial support.
6. Adverse Event, Vigilance Reporting and Field Actions
Complete and maintain incident reports, including submission of Medical Device Reports (MDR) and Vigilance Reports when necessary. Performs periodic trending and reporting of Medical Incidents (monthly, quarterly, annual summaries, as required); Chair weekly Complaint Review Meetings; Participate in Quality Data Reviews, Management Review Meetings and CAPA Review Board Meetings; Analyze/evaluate data and draw conclusions based on evaluations. Manages the execution of field actions to assure timeliness to include project management, development of customer communication, reporting to the appropriate regulatory agencies, tracking field action effectiveness, and agency status reports. Respond to agency inquiries related to field actions and/or adverse events.
7. Post Market Surveillance
Manage team of contributors on post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of post market status and metrics. Perform trending and analysis as well as Post Market Surveillance activities including compiling reports for Apyx Medical products.
8. Collaboration & Integration
Provide guidance and expertise to business partners for the interpretation, implementation, and execution of requirements related to product complaint investigations, adverse event determination and vigilance reporting, field actions and post market surveillance – provide coaching, training, and development of personnel in in these areas. Build working relationships with cross functional teams including Development, Supply Chain, Manufacturing Operations, Commercial Operations, Quality Assurance, Clinical Education and Marketing to ensure process solutions are compliant, efficient, and adaptable to the business. Lead new business projects (external manufacturers, distributed products) to ensure compliant and effective data / knowledge transfer. Present to senior management complaint investigation and post market outcomes and interact with Device Experts/Product Quality Owners/Product Quality Integrators to recommend improvements and improve overall risk profile of Apyx Medical products. Support Regulatory and Field Actions Committees, FDA inspections, Health Authority Inspections, and other types of regulatory agency inspections/audits. Ensure integration of Post Market Process into all facets of the QMS including management controls, Corrective and Preventive Actions, and Risk Management.
9. Other duties and projects, as assigned.
SUPERVISORY RESPONSIBILITIES: The Regulatory Affairs Manager will assume responsibility for three or more direct reports.
a. Accomplish Pre and Post Market Regulatory Affairs human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures. Complete Pre- and Post-market regulatory affairs operational requirements by scheduling and assigning employees; following up on work results.
b. Manage Pre and Post Market Regulatory Affairs staff by recruiting, selecting, orienting, and training employees.
c. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Update job knowledge by studying trends in and developments in Pre and Post Market Regulatory Affairs; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
d. Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
e. Achieve financial objectives by estimating requirements, preparing an annual Pre and Post Market Regulatory Affairs budget; scheduling expenditures; analyzing variances; initiating corrective actions.
f. Contribute to team effort by accomplishing related results as needed.
The requirements listed below are representative of the knowledge, skill, and/or abilities required.
EDUCATION AND EXPERIENCE
Bachelor’s Degree in Engineering or Science; 6-12 years of experience in Regulatory Affairs with strong medical device product development and manufacturing experience, preferably with active medical devices. Knowledge of electrical safety standards and principles of software validation. Also, knowledge in Investigations, Root Cause Analysis, Complaint Handling, Statistical Analysis, Risk Management, Design Control, Process Validation, FMEA/Risk Assessment, and ISO/QSR; RAC or ASQ certifications preferred.
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 absolute discretion.
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