Sr. Regulatory Affairs Specialist

POSITION SUMMARY:

Provide global medical device regulatory expertise in the day-to-day operations of the department and support the Manager, Regulatory Affairs in all aspects of obtaining and maintaining the required governmental product registrations worldwide. Support management and the needs of the business with the implementation of departmental strategies, polices and maintain complete and accurate documentation of all regulatory related files, both paper and electronic. Take a lead role in regulatory projects and participate in global, cross-functional teams that are working on approval for a range of medical device products in various countries.

SUPERVISORY RESPONSIBILITIES: None

PRIMARY FUNCTIONS:

1. Prepare and support regulatory submissions for product approvals and renewals for United States FDA, European Community, Brazil ANVISA, China NMPA, Health Canada and the rest of world.

2. Submit regulatory filings and associated deliverables by effectively managing and communicating with domestic and international contractors and consultants to ensure deliverable deadlines are met.

3. Support product development projects and changes to existing products to ensure that they are conducted in compliance with the appropriate regulations by leading routine reviews and maintaining proper documentation.

4. Ensure compliance with the company’s Quality and Regulatory strategies and procedures across departments, including the coordination and documentation of internal regulatory processes such as internal audits, inspections, and license renewals.

5. Review labeling, advertising and marketing material changes to ensure accuracy and regulatory compliance.

6. Participate in the complaint handling process and assist in determining the regulatory reportability and electronic submission as required by FDA and other regulatory bodies.

7. Support regulatory inspections and audits.

QUALIFICATIONS:

Education/Training/ Certifications/Licenses:

A. Bachelor’s Degree in a scientific, engineering or Regulatory Affairs field. Master’s Degree preferred.
B. 5+ years experience with medical device regulatory submissions.
C. Regulatory Affairs Certification (RAC) preferred.

Experience:

A. Experience in full-life cycle Regulatory Affairs procedures, processes and life-cycle development. Must have some hands on CE Mark and US FDA 510(k) experience as well as knowledge and understanding of basic global regulatory requirements and procedures for filing new applications and renewing existing applications for medical devices.

B. Project management experience with the ability to successfully manage multiple priorities.

C. Design Control experience from design inception to product launch.

D. Have proven success in international registrations, and direct experience with CE Mark registrations specifically. Knowledge of the registration process in China and South America is a plus.

E. Experience with managing labeling, advertising and marketing material changes to ensure accuracy and regulatory compliance.

F. Experience with complaint handling process and determining the regulatory reportability and electronic submission as required by MDR, the FDA and other regulatory bodies.

Skills/Abilities:

A. Must have a general ability to read and interpret country specific filing requirements in various other countries.

B. Have a good understanding of the 510(k) and CE Mark process and requirements.

C. Ability to interpret global regulatory regulations as they relate to the company’s medical devices and solutions.

D. Excellent written and verbal communication skills, finesse in dealing with difficult situations and the ability to demonstrate leadership skills.

E. Microsoft Office (MS Word, MS Excel, etc.), document management software, Adobe Acrobat

F. Multi-task in a faced-paced and deadline driven environment.

Physical Demands:
Strength/Bend/Lift: Occasional lifting up to 10 pounds
Sit/Stand %s: Sitting 90%, Standing 10%
Manual Dexterity: Keyboard, filing
Work Environment: Normal office environment
Travel: Occasional (<10%) travel, domestic and potentially international, is required.
Hours: Approx. 40 hours per week

Job Type: Full-time

Pay: From $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Experience level:

• 6 years

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• medical device regulatory submission: 5 years (Required)
• FDA regulations: 5 years (Required)

Work Location: Hybrid remote in Itasca, IL