1+ months

Director of Regulatory Affairs

Kelly Services
Miami, FL 33126
I have an exciting **Direct Hire** opportunity for an **Director of Regulatory Affairs!** The client is located in **Miami, FL** but this position can be **Full-Remote Role.**

The Director of Regulatory Affairs will be responsible for the coordination, compilation and submission of biologics and medical device applications in addition other various submissions to regulatory agencies. This person will be responsible for developing and implementing Chemical and Manufacturing Controls (CMC). This role will also provide guidance to project teams on the current regulatory framework from the Food and Drug Administration (FDA) to ensure the added value to the business from the commercialization of medical products. The Director of Regulatory Affairs will be responsible for managing supplier and distributor qualifications and the companys auditing program as well as maintaining voluntary accreditations, state licenses and establishment registrations and listings.

**Duties and responsibilities**

1. Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials.

2. Manage supplier and distributor qualifications and the organizations internal and external auditing program.

3. Work with multidisciplinary teams on the commercialization to ensure compliance with FDA regulations including:

a. Coordination, compilation, and submission of regulatory filings including but not limited to: Requests for Designation (RFD), Investigational New Drug (IND), Biologics License Application (BLA), 510(k), and Pre-Market Approval (PMA).

b. CMC development and implementation

c. Support of clinical trial protocol development

4. Oversee and maintain licensing, registration, and accreditation with the different state, federal, and independent regulatory bodies.

5. Support and maintain regulatory reporting endeavors including but not limited to MedWatch, and Biological Product Deviations.

6. Remains current in industry trends and practices up to and including association memberships with committee or work group participation. Identifies patterns to improve processes. Assists in the development and improvement of policies and procedures for all aspects of business, to include data collection and regulatory compliance.

**Education Required**

Bachelor of Science or Arts in a relevant discipline is required.

Experience: Minimum of 7 years Tissue Bank, Medical Device, Biologics or

Pharmaceutical experience with 4 years management experience


**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-06-21 Expires: 2021-09-20

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Director of Regulatory Affairs

Kelly Services
Miami, FL 33126

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