Regulatory Affairs Manager

Job Description

Job Description

Regulatory Affairs Global Compliance Manager

Summary / Purpose

Under general guidance, the Regulatory Affairs Global Compliance Manager is responsible for regulatory submissions, registrations, and licensing (both domestic and foreign) and for ensuring company compliance with applicable regulatory requirements (both domestic and foreign); including FDA, Council of European Communities, Directive for Medical Devices, Canadian Medical Device Regulations, and others as identified by the Regulatory Affairs Department.

Essential Functions

1. Prepare regulatory submissions, registrations, and licensing documentation.

2. Ensure that processes needed for regulatory compliance are established, implemented, maintained, and continuously improved.

3. Supervise and coordinate all positions related to Regulatory Affairs.

4. Evaluate product and product concepts for compliance with the appropriate governing regulatory requirements.

5. Evaluate international authorized distributors.

6. Monitor company for compliance with Regulatory Standards and the Quality Management System (QMS).

7. Interface, as the primary contact, with State, Federal, and International Agencies (Management Representative).

8. Serve as the primary lead (host) for regulatory and notified body / ISO Registrar audits.

9. Interface with Notified Body / ISO Registrar and applicable foreign distributor regulatory departments regarding applicable product issues, product changes, or quality system changes.

10. Monitor and report to top management the applicable regulatory requirements.

11. Advise on regulatory issues and ensure the promotion of regulatory requirements throughout the organization.

12. Provide regulatory guidance to departments, communicate regulatory information, and ensure that the information is interpreted correctly.

13. Plan, prepare, and conduct Management Review meetings.

14. Perform regulatory documentation review.

15. Plan and implement QMS and applicable regulatory training.

16. Manage and continuously improve the internal audit system.

17. Manage and continuously improve the customer Complaints / Feedback System.

18. Manage and continuously improve the regulatory adverse event reporting system.

19. Manage and continuously improve the product recall and advisory notice systems.

20. Manage and continuously improve clinical evaluations.

21. Plan, schedule, and follow up on QMS audits (external, internal, and regulatory).

22. Support OEM customer audits.

23. Clarify, define, and defend regulatory policy.

24. Supervise employees making decisions regarding hiring, firing, discipline, and performance evaluations.

25. Communicate with coworkers at all levels.

26. Required to be present in the workplace during scheduled work hours.

27. Ability to work independently to perform daily operating tasks.

Marginal Functions

Participate in other work functions as directed.

Physical Demands

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 this job :

• The employee is regularly required to sit, stand, and intermittently walk, using hands and fingers for keyboard, phone, and to handle or feel.
• The employee is frequently required to reach with hands or arms and talk and hear.
• The employee frequently will use either one or both hands to firmly grasp, push, and / or pull.
• The employee will occasionally reach overhead to grasp objects and lift or carry up to 40 lbs.
• It will be necessary to be around equipment and machinery and work in an office or warehouse environment.
• Normal 20 / 20 vision (with corrective lenses, if needed) required.

Qualifications and Requirements

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required.

Education

Bachelor's degree and two to four years related experience or equivalent combination of education and experience.

Skills

1. Knowledge of current 21 CFR, ISO 13485, ISO 14971, and clinical evaluation standards.

2. Knowledge of medical device manufacturing or related field.

3. Ability to guide and delegate to subordinates.

4. Ability to demonstrate leadership in job performance by example.

5. Knowledge of FDA QSRs.

6. Skill in assessing performance.

7. Ability to analyze training needs.

8. Ability to administer employee discipline.

9. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations.

10. Ability to write reports, business correspondence, and procedure manuals.

11. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

12. Ability to be flexible in changing daily workload priorities as directed.

13. Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.

14. Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.

15. Ability to coordinate and synchronize multiple projects.

16. Must be able to present a professional attitude in auditing and other external contact situations.

17. Manual dexterity required and ability to accurately perform detail-oriented work.

18. Ability to read, understand, and accurately complete documentation in English.

19. Ability to effectively communicate in English with auditors, customers, suppliers, and other employees.

20. Ability to maintain composure when dealing with difficult customers, auditors, or suppliers.

21. Ability to understand and apply biocompatibility concepts and standards.

22. Ability to understand sterilization and packaging concepts and standards.

23. Ability to understand silicone physical properties.

24. Ability to understand silicone molding processes.

25. Ability to understand and apply risk management concepts and standards.

26. Ability to present departmental data clearly to an audience ranging from line personnel up to top management.

Mathematical Skills

Ability to apply advanced mathematical concepts such as exponents, logarithms, linear equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling, and factor analysis.

Computer Skills

Basic computer knowledge (Windows platform). Knowledge of Word, Excel, Access, and Outlook required.

Experience

5+ years of related experience administering key quality system elements preferred. Familiar with the use of analytical equipment. Advanced Excel knowledge. Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Training

Training requirements for this position are outlined in the Required Employee Training Matrix.