Sr. Pre-Market Regulatory Affairs Specialist

Department: Regulatory Affairs
Reports to: RA Director
FLSA Status: Exempt

SUMMARY

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

1. 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.
2. Assist Regulatory leadership to develop, maintain, and execute domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
3. 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;
4. 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.
5. 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.
6. 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.
7. 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.
8. Execute the regulatory review of labels, labeling, advertising and promotional materials; Review labeling/promotional/advertising materials, and other documents to ensure compliance.
9. Develop policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
10. 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.
11. Provide training to cross-functional teams on a various regulatory issues and processes.
12. Act as a mentor to other junior Regulatory Affairs associates, participating in development discussions and assisting other associates with developmental tasks and projects.
13. 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.
14. Independently manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision.
15. Other Duties as assigned.

Requirements
QUALIFICATIONS

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.

EXPERIENCE

• 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.

LANGUAGE SKILLS

Fluent in English. Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries from regulatory agencies. Ability to effectively present information to personnel of all levels from top management to entry level employees.

COMPUTER SKILLS

Proficiency with Microsoft Excel, Word, Power Point and Microsoft Project is required. Familiarity with Macola is required to include Item Master features, Bill of Materials, Sales History and other related subjects. Proficiency in Trackwise to include the approval of Complaint Records and Child Record Investigations; Corrective and Preventive Actions and Effectiveness Checks; and review of Non Conformance Records as needed.

MATHEMATICAL SKILLS

Ability to adapt advanced mathematical concepts such as Statistical Techniques, exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis or variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. High degree of judgment and integrity required to deal with complex factors not easily evaluated and make decisions based on conclusions for which there is little precedent.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to stand, sit, and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to the risk of electrical shock. The noise level in the work environment is usually moderate.

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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