Principal Regulatory Affairs Specialist

Department: Regulatory Affairs
Reports to: Regulatory Affairs Manager – Pre-Market
FLSA Status: Exempt

POSITION SUMMARY

The Principal Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderate to highly complex regulatory registrations; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; managing RA activities by setting priorities, providing guidance and development to junior level Specialists. Additionally, the Principal Regulatory Affairs Specialist will play a critical role in regulatory approval efforts by developing regulatory strategy, executing regulatory plans, and performing other activities that lead to and maintain regulatory approval/clearance/licensure for Apyx’s medical devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Plan, coordinate, and prepare regulatory submissions of various types, including US FDA 510(k) premarket notifications, IDE submissions and supplements, EU technical documentation, internal “Letters to File”, and international dossiers as applicable
2. Lead regulatory activities associated with transitioning CE Marked products to the new requirements of the European MDR.
3. Ensure Technical Documentation and the EU declaration of conformity are drawn up and kept up-to-date
4. Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance/approval/registration of medical devices
5. Communicate submission requirements to product development and process improvement teams
6. Works with product development team to resolve potential regulatory issues and questions from regulatory agencies.
7. Review and approve design, product, and manufacturing changes for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
8. Determine, review, approve, manage, and maintain labeling and labeling requirements, including IFUs
9. Serve as internal consultant to project teams, providing Regulatory Affairs feedback and guidance on new product development, design changes, as well as other proposed changes that may require regulatory inputs
10. Maintain annual facility registrations, device listings, and UDI/GUDID/EUDAMED codes as appropriate
11. Provide support to currently marketed products as necessary
12. Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams
13. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel
14. Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
15. Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
16. Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
17. Provide regulatory input to product lifecycle planning.
18. Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
19. Provide feedback and on-going support to product development teams for regulatory issues and questions.
20. Provide assistance with Regulatory inspections and audits
21. Ensure personal understanding of all quality policy/system items that are personally applicable.
22. Follow all work/quality procedures to ensure quality system compliance and high-quality work
23. Other Duties as assigned.

Requirements
BASIC QUALIFICATIONS

Bachelor’s Degree (BA/BS) from a four-year College or University; Advanced degree and/or RAC certification preferred.

EXPERIENCE

  • Minimum 7-10 years of medical device regulatory experience (Class II or III)
  • Solid knowledge of medical device regulations, 510(k) and/or Premarket Approval (PMA) process. Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Documentation and other regulatory documentation). Experience with US FDA Class II/III medical device submissions.
  • Experience working directly with FDA, notified bodies and/or international health authorities.
  • Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
  • Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
  • Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
  • Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues.

ATTRIBUTES & CRITICAL COMPETENCIES

  • Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
  • Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
  • Able to present to multiple levels and departments within the organization; Strong interdependent partnering skills, interpersonal communication, influencing skills without direct line authority.
  • Able to support change initiatives, develop strong effective relationships with key resources and decision makers.
  • Demonstrated knowledge and expertise of post market surveillance, field actions, and complaint vigilance global regulatory requirements.
  • Knowledge of domestic and international quality systems and other standards such as FDA QSR, EU MDR, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations
  • Able to lead an organization through continuous improvement and change; Competency in understanding system functionality in relation to process requirements.
  • 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 absolute discretion.

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