Regulatory Affairs Expert

Position Summary

In this role, you will be responsible for the preparation of regulatory submission documents for both domestic and international markets, as well as evaluating manufacturing modifications and marketing materials from a regulatory perspective.

Key Responsibilities

1. Ensure the acquisition and maintenance of all necessary licenses, registrations, and listings, including US Wholesale Drug Distribution Licensing.
2. Proficient in International Device Registrations.
3. Lead International Product Registration initiatives to successful completion.
4. Engage with regulatory bodies throughout the development and review phases to secure submission approvals.
5. Compile regulatory submissions, including 510(k) submissions, and assist in the preparation of IDE and PMA documentation.
6. Track and submit relevant reports, ensuring timely responses to regulatory authorities.
7. Collaborate with Research and Development to establish and implement pre-clinical testing strategies supporting regulatory submissions.
8. Provide regulatory documentation and product information to support global sales efforts, maintaining the FDA Certificate to Foreign Government.
9. Prepare responses to inquiries from customers, partners, and regulatory agencies regarding product data and compliance.
10. Review and authorize domestic and international product labeling, promotional content, packaging, and advertising materials, conducting regulatory evaluations for any changes to marketed products.
11. Assess compliance with internal Quality System regulations.
12. Ensure that the regulatory standards referenced within the company’s Quality System are appropriate.
13. Stay informed about current and upcoming legislation affecting regulatory requirements, updating internal processes as necessary.
14. Guarantee adherence to post-marketing approval obligations.
15. Manage Product Complaints System reporting, including FDA MDRs, EU Vigilance, and Canadian Medical Device reporting.
16. Support activities related to product recalls and safety issues, ensuring timely reporting to regulatory agencies.
17. Guide cross-functional teams in meeting regulatory standards and supporting product filings.
18. Assist Quality Assurance in the development and upkeep of CE Technical Files, Clinical Evaluation Reports (CER), and Essential Requirements Reports (ERR).
19. Maintain Declarations of Conformity.
20. Evaluate proposed document modifications to determine their impact and necessary submission requirements.
21. Provide regulatory insights for inspections and audits, accompanying inspection teams as needed.
22. Contribute to the formulation of departmental policies and regulatory strategies.
23. Foster effective relationships with regulatory authority reviewers and internal stakeholders.
24. Exhibit professionalism and high ethical standards in all interactions with regulatory authorities and colleagues.
25. Represent the organization positively and supportively at all times.
26. Act as the company’s Person Responsible for Regulatory Compliance (PRRC) if designated.

Additional Responsibilities

1. Travel for conferences, seminars, or business as required.
2. Engage in professional associations and industry groups at various levels.
3. Stay updated on regulatory affairs by networking with other professionals in the field.
4. Review documentation prepared by others for clarity and compliance with company policies and regulations.
5. Report departmental activities to senior management.
6. Undertake other projects as assigned.

Education and Experience

A Bachelor’s degree in a scientific discipline is required, along with three to five years of relevant experience, or an equivalent combination of education and experience. Previous experience in medical device regulation is preferred.

Qualifications

To excel in this position, candidates must demonstrate the ability to fulfill essential duties effectively. The following skills and abilities are essential:

Language Proficiency

Ability to comprehend and interpret complex scientific and regulatory documents. Capable of addressing intricate regulatory issues and drafting technical reports and correspondence.

Mathematical Skills

Ability to apply mathematical concepts such as fractions, percentages, and ratios to practical scenarios.

Technical Skills

Proficient in word processing, spreadsheet, and database applications, with the ability to learn new software programs.

Certifications

A Regulatory Affairs certification is advantageous.

Knowledge, Skills, and Abilities

Familiarity with FDA QSRs, U.S. Food, Drug, and Cosmetic Act, Canadian Medical Device Requirements, European Union Medical Device Requirements, and ISO 13485.

Ability to work independently, take initiative, and make informed decisions within established guidelines.

Strong negotiation, organizational, interpersonal, and reasoning skills.

Capacity to maintain accurate documentation systems and communicate effectively with various stakeholders.

Flexibility to adapt to changing priorities and manage multiple projects efficiently.

Ability to function in a regulated environment while handling confidential information responsibly.

Willingness to travel for business purposes, including overnight stays.

Physical Demands and Work Environment

The physical demands and work environment characteristics 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 the job, the employee is regularly required to stand, walk, sit, talk, hear, and use hands repetitively. The employee is occasionally required to use hands to finger, handle, or to feel; to use hands to grasp; to use extended reach with hands; to use fine dexterity with both hands; and lift or move up to 10 lbs. Normal vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet.

Compensation and Benefits

The compensation range for this position is competitive and commensurate with experience and qualifications. DenMat offers a comprehensive benefits package, including medical, dental, vision, and prescription coverage, life insurance, a 401(k) plan with matching contributions, paid time off, and employee assistance programs.

Equal Opportunity Employer

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer. Employment decisions are based on merit, competence, and qualifications without regard to race, color, religion, national origin, gender, age, disability, or any other legally protected status.