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Senior Regulatory Specialist

Company: N/A

Location: Gainesville, FL

Pay: $95,000.00 - $120,000.00 /Year

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Job Description



Senior Regulatory Specialist





Duties and Responsibilities (Key Deliverables):





1. Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices.

2. Preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.

3. Providing regulatory strategy and support for new product development projects:





a. Design team participation

b. Design Control requirements

c. CE marking requirements / Technical File (STED) / Design Dossier compilation

d. Pre-market regulatory submissions

e. Canadian device license applications

f. International product registrations – STED File organization

g. Product labeling review and approval





4. Independently manage medium to large scale regulatory project initiatives

5. Provide input into corporate regulatory strategies

6. Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.

7. Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.

8. Knowing and applying Quality Management System and any appropriate federal and international standards.

9. Providing knowledge and support to the company's different business units to enable operation within company and regulatory guidelines.

10. Assisting and supporting other employees, teams, and sales personnel as necessary.

11. Practicing Company Values.



Job Requirements:



Education: Bachelor's Degree from an accredited institution required.



Experience:



• Minimum 5 years experience in FDA/ISO medical devices quality management system standards required.

• 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required.

• Technical writing skills required.

• Experience in Design Controls.

--Relocation Assistance is also offered depending upon where the Candidate is coming from



Functional/Technical Knowledge, Skills and Abilities Required:



• Working knowledge of windows based office productivity tools including word processor and spreadsheet.







Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.


Job Requirements