Regulatory Affairs Specialist
Every day, Kelly Scientific Resources (KSR) connects
clinical research professionals with opportunities to
advance their careers. We currently have an exciting
contract opportunity for a Regulatory Affairs Specialist
working with our client based in Jacksonville, FL.
Job Responsibilities (other duties may be assigned):
manufacturing changes for client products and
- Maintains database for tracking change requests.
- Reviews, analyzes and evaluates post approval
determine the appropriate regulatory pathway.
and PMA products.
- Prepare internal documentation in support of 510 k
Supplements and FDA Annual Reports.
- Assist with the technical preparation of PMA
- May provide regulatory support for business critical
Pharmaceutical or Medical Device Regulatory
- Bachelors Degree - Scientific Discipline preferred.
- 1 - 2 years of working experience within the
and interpersonal skills.
- Strong communication, organizational, negotiation
principles, concepts and practices of FDA
- General knowledge, understanding and application of
issues or gaps.
- Ability to organize and analyze data and identify
boundaries of Regulation.
- Ability to provide innovative solutions within the
- Proficient use of Microsoft Office Suite including
transportation needed to work between campuses.
- No travel required with the exception of local
- Maintains the change request database.
- Reviews change requests and documents the regulatory
reports to FDA.
- Prepares and submits PMA supplements and annual
requirements and coordinates the collection of data
- Assists project teams with identification of data
and documents to meet post approval submission.
- Performs other related duties as assigned by
For immediate consideration, click the Apply Now button,
or refer a friend by clicking the E-mail this job link
Kelly Scientific Resources® has grown into a $270
million global business as the scientific business unit
of Kelly Services. Our recruiting consultants place
clinical, regulatory and medical affairs, data
management and biostatistics professionals to the
pharmaceutical, biotechnology, medical device, CRO and
university research communities.
We invite you to bookmark our Web site and encourage you
to review it regularly for new opportunities worldwide:
Kelly Services is an Equal Opportunity Employer.
Job Code : BHJOB3479_596919
Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...