Regulatory Affairs Specialist I
(Pre and Post Market)
Department: Regulatory Affairs
Reports to: Regulatory Affairs Director
FLSA Status: Exempt
The Regulatory Affairs Specialist assumes responsibility for assisting and 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 Specialist is the liaison for communication with regulatory agencies and regulatory agency inspections.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Ensure Compliance with Labeling Regulations by reviewing package inserts, cartons and labels with regard to both content and format.
- Support internal and external quality audits related to labeling.
- Actively support CAPA’s as they apply to labeling.
- Partner with Translation Coordinator(s) throughout the execution of the associated labeling plans.
- Maintain proficiency in domestic and foreign regulations and standards, with a focus on labeling for assigned products and global impact.
- Obtaining and maintaining GTIN numbers and GUDID Registrations.
- International Regulatory Affairs:
- Assist on filling the 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.
- Reviewing product changes for impact on regulatory filings worldwide, license renewals, periodic updates and registrations to regulatory agencies.
- Complaint Handling:
- Perform 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.
- Support complex investigations, coordinate and support Failure Investigations and participate in projects related to complaint handling.
- Assist in Customer Defect Tracking and Resolution to improve the overall customer experience.
- Coordinate flow of returned product for proper investigation; communicate as needed with OEM customers, distributors and doctors/nurses at user facilities.
- Adverse Event, Vigilance Reporting & Field Actions:
- Complete and maintain incident reports, including submission of Medical Device Reports (MDR) and Vigilance Reports when necessary.
- Perform periodic trending and reporting of Medical Incidents (monthly, quarterly, annual summaries, as required).
- Assist in 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.
- Post Market Surveillance:
- Contribute to 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. Monitor metrics based on performance trends.
- Perform trending and analysis as well as Post Market Surveillance activities including assisting in compiling reports for Bovie Medical products.
- Other Duties as assigned.
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
Bachelor’s Degree (BS) from a four-year college or university in a technical, regulatory, engineering and/or scientific discipline, or equivalent regulatory/scientific experience; 1-2 years applicable regulatory/scientific experience.
- Able to support change initiatives, develop strong effective relationships with key resources and decision makers.
- Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations
- Able to maintain up-to-date knowledge and ensure proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
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: Human Resources, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760-4004 or e-mail email@example.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