Sr. Regulatory Affairs Specialist III (Pre-Market)
Department: Regulatory Affairs
Reports to: Regulatory Affairs Manager
FLSA Status: Exempt
Senior Regulatory Affairs Specialist III will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; executing regulatory product submissions from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and pre-market activities, as required; exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Maintain current knowledge of relevant regulations, including proposed and final rules; Interpret regulatory/compliance policies and guidance and correctly apply them as regulatory activities, and guide in these activities; Interpret statutes, regulations, policies and guidance documents for business teams and product development/support teams. Communicate impact to product development, manufacturing, and/or marketing teams.
- Assist Regulatory leadership to develop, maintain, and execute domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
- Assess regulatory pathways for new product platforms and product modifications; develop regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies; Identify and communicate potential risks and risk mitigation strategies to stakeholders;
- Manage planning and preparation of regulatory submissions (510(k), Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international regulatory agencies, including submissions for pre- and post-market requirements. Ensure regulatory submissions are prepared and processed in a proactive, expeditious and timely manner; Accountable for establishing, maintaining, adjusting and communicating regulatory submission deadlines to ensure that all product-launch related functional area activities can be planned accordingly.
- Represent the business in interactions with regulatory authorities. Play a prominent role in complex negotiations regarding clinical and analytical study designs during the product development (pre-submission) phase, as well as the appropriateness of product claims, wording, and interpretation/presentation of performance during the verification/validation (pre-clearance/approval) phase.
- Participate on cross-functional product development teams representing the Regulatory Affairs function; Assist in the planning and design of internal studies (including feasibility studies), clinical studies and post-market studies in support of US FDA and international regulatory submissions.
- Create and maintain product instructions for use, artwork, and other labeling by working with cross-functional teams (marketing, R&D, quality, etc.) and external parties (translation and design companies) to meet the requirements set forth by the company, US FDA and international regulatory agencies.
- Execute the regulatory review of labels, labeling, advertising and promotional materials; Review labeling/promotional/advertising materials, and other documents to ensure compliance.
- Develop policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
- Remain current on regulatory issues/trends affecting the Company’s products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business.
- Provide training to cross-functional teams on a various regulatory issues and processes.
- Act as a mentor to other junior Regulatory Affairs associates, participating in development discussions and assisting other associates with developmental tasks and projects.
- Maintain proactive and positive working relationships with internal and external customers, both US and ex-US, to ensure the business is positioned to meet strategic corporate goals.
- Independently manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
- Other Duties as assigned.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities in the area of physical demands and work environment.
EDUCATION & CERTIFICATIONS
Bachelor’s Degree (BA/BS) from a four-year College or University in a technical, regulatory, engineering and/or scientific discipline or equivalent regulatory/scientific experience; Advanced degree and/or RAC certification preferred.
- Minimum 5-8 years of directly related regulatory experience in the medical device (Class II or III) arena.
- 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 Files 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.
- 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 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 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