Regulatory Compliance Analyst

1 week ago

Lompoc, California, United States DenMat Holdings, LLC Full time
Job Overview

Position Summary

Under general supervision, the role involves the preparation of regulatory documentation for submissions to the FDA and international regulatory bodies, as well as evaluating regulatory implications of manufacturing modifications and marketing materials.

Key Responsibilities include but are not limited to:

  1. Ensure the acquisition and maintenance of all necessary licenses, registrations, and listings, including U.S. Wholesale Drug Distribution Licensing.
  2. Proficient in International Device Registrations.
  3. Lead International Product Registration initiatives to successful completion.
  4. Engage with regulatory authorities throughout the development and review phases to secure submission approvals.
  5. Compile regulatory submissions, including 510(k) applications; assist in the creation of IDE and PMA documentation.
  6. Track and submit relevant reports, ensuring timely responses to regulatory bodies.
  7. Collaborate with Research and Development to formulate and implement pre-clinical testing strategies supporting regulatory submissions.
  8. Provide regulatory documentation and product information to agents and distributors to facilitate global sales. Maintain FDA Certificate to Foreign Government.
  9. Draft responses to inquiries from customers, trading partners, and regulatory agencies regarding product data and compliance.
  10. Review and endorse domestic and international product labeling, promotional content, packaging, and advertising materials. Conduct regulatory evaluations for modifications to marketed products.
  11. Assess internal Quality System compliance with regulatory standards.
  12. Ensure that the regulatory standards referenced within the DenMat Quality System are appropriate.
  13. Stay informed on current and forthcoming legislation affecting regulatory obligations and adapt internal procedures accordingly.
  14. Guarantee adherence to post-marketing approval requirements.
  15. Manage Product Complaints System reporting, including FDA MDRs, EU Vigilance, and Canadian Medical Device reporting.
  16. Support product-related events and recall activities, ensuring safety issues are reported to regulatory agencies. Aid in the development and implementation of SOPs for tracking product-related events.
  17. Advise cross-functional teams on regulatory requirements to support product filings.
  18. Assist Quality Assurance in the creation and upkeep of CE Technical Files, Clinical Evaluation Reports (CER), and Essential Requirements Reports (ERR).
  19. Maintain Declarations of Conformity.
  20. Evaluate proposed document changes to assess impact and submission requirements, including Notified Body Notices of Change.
  21. Provide regulatory insights for inspections and audits, accompanying inspection teams as necessary.
  22. Contribute to the formulation of departmental policies and regulatory strategies.
  23. Foster productive relationships with regulatory authority reviewers and colleagues.
  24. Exhibit professionalism and high ethical standards in all interactions with regulatory authorities and peers.
  25. Represent the organization positively and supportively at all times.
  26. Act as the company's Person Responsible for Regulatory Compliance (PRRC) if required.

Additional Responsibilities may include:

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

Supervisory Role

This position does not entail supervisory responsibilities.

Education and Experience

A Bachelor’s degree in a scientific discipline and 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 role, candidates must demonstrate the ability to perform essential duties effectively. The following skills and abilities are essential:

Language Proficiency

Ability to comprehend and interpret complex scientific and regulatory documents. Proficient in drafting technical reports and responding to regulatory inquiries.

Mathematical Proficiency

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

Technical Skills

Proficient in word processing, spreadsheet, and database applications. Capability 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.

Demonstrated professional communication skills, both verbal and written, with the ability to work independently and make informed decisions.

Strong negotiation, organizational, and interpersonal skills, with the ability to manage documentation systems effectively.

Ability to adapt to changing priorities and maintain accuracy in a fast-paced environment.

Proficient in using MS Word, Excel, FileMaker Pro, and PowerPoint, along with various office equipment.

Physical Requirements and Work Environment

The physical demands and work environment characteristics described are representative of those necessary for successful job performance. Reasonable accommodations may be made for individuals with disabilities.

Regularly required to stand, walk, sit, talk, hear, and use hands repetitively. Occasionally required to lift or move up to 10 lbs. Normal vision ability is required for this position.

Compensation and Benefits

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

Equal Opportunity Employment

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

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