Pre-Market Regulatory Affairs Specialist II
Department: Regulatory Affairs
Reports to: RA Manager – Pre-Market
FLSA Status: Exempt
Regulatory Affairs Specialist II (Pre-Market) will be responsible for supporting regulatory strategies in domestic and global submissions, including the US, EU, Canada, Australia, Brazil, and other International submissions. Providing Quality System based activities for documentation, including Change Management and Creation of Labeling and Instructions for Use.
POSITION RESPONSIBILITIES (not limited to any combination and new tasks may be assigned)
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 Management or more tenured Regulatory Affairs Specialists in executing domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
3. Support International Submission requests and Lead International Renewals and International Audit efforts. Preparation of export certificates.
4. 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.
5. Assess regulatory pathways for 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 Regulatory Management and cross-functional stakeholders.
6. Manage updates to Technical Files, Technical Documentation and other regulatory and quality system documentation using Change Management procedures and Quality System portal.
7. Participate on cross-functional product development teams representing the Regulatory Affairs function;
8. Follow policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
9. 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.
10. Provide training to cross-functional teams on various regulatory issues and processes.
11. Act as a peer mentor to other junior Regulatory Affairs associates or new team members, as needed.
12. 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.
13. Independently manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas with limited supervision.
14. Other Duties as assigned.
QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements including but not limited to:
1. Use only formally approved procedures, records, documents and specifications known as “Control Documents” (e.g., device history records, data collection forms, drawings, procedures, and specifications).
2. Use only properly calibrated and maintained equipment.
3. Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.
4. Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.
5. Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.
6. Ensure all purchasing documents are completed to Work Instructions.
Overall Duties and Percentage Effort
- Labeling and Instruction for Use – 30%- 50%International Regulatory Affairs – 30%
- Change Management and Periodic Updates – 10%
- Other duties as assigned – 10%
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.
LANGUAGE SKILLS: Ability to respond to common inquiries from members of the business community. Ability to effectively present information to personnel of all level employees. Candidates must be proficient in either French, Spanish, or Italian, as well as English.
- Minimum 1-2 years of directly related regulatory, labeling, or technical communications experience in the medical device.
- Basic knowledge of Regulatory Affairs, Quality Management System, Labeling and IFU requirements for medical devices.
- Experience working directly with FDA, notified bodies and/or international health authorities.
- Demonstrated success understanding technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
ATTRIBUTES & CRITICAL COMPETENCIES
- Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
- 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 maintain up-to-date knowledge and ensure proactive compliance with FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
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.
Proficiency with Microsoft Excel, Word, Power Point and Microsoft Project is required. SalesForce/Propel, Adobe InDesign, Photoshop, Illustrator, and Label Matrix are desired.
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.
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.
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.
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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