Regulatory affairs specialist Jobs in Birmingham al
- Promoted
Regulatory Affairs Associate I
BIOHORIZONS IMPLANT SYSTEMSBirmingham, AL, US
Medical Director (Medical Affairs)
CVS HealthAlabama, Work At Home, US
Govt Affairs / Com Relations Mgr BIRMINGHAM
D.R. HortonHoover, AL
FINANCIAL AFFAIRS COORDINATOR
UABBirmingham, Alabama, US
National Tax Services - Tax Controversy Regulatory Services - Director
PwC US Tax LLPBirmingham,AL- Promoted
- Promoted
- New!
Regulatory Affairs Manager
Early Autism ServicesVestavia Hills, AL, US- Promoted
Assistant General Counsel - Legal Affairs
City of New YorkBirmingham, Alabama, US
Accreditation and Regulatory Specialist
Children's of AlabamaBirmingham, AL, United States- Promoted
Vice President, Regulatory Compliance
Behavioral Health SystemsBirmingham, Alabama, US
Senior Regulatory Implementation & Assurance Analyst
Highmark HealthAL, Working at Home, Alabama- Promoted
Marketing Specialist
FYZICAL Therapy and Balance CentersHoover, AL, US
Energy Efficiency Regulatory Consultant
ClearesultAlabama- Promoted
Intake Specialist
Providence Staffing LLCBirmingham, AL, United States- Promoted
Director, State Affairs
Alzheimer's AssociationBirmingham, AL, United States
International Affairs Consultant
Centrik Global ConsultingWashington County, Alabama, United States
Sr. Business Analyst- Regulatory Reporting
PNC Bank NABirmingham , ALRegulatory Affairs Associate I
BIOHORIZONS IMPLANT SYSTEMSBirmingham, AL, US- Full-time
Job Description
Job Description
The Regulatory Affairs Associate I can heavily influence the company's compliance with various initial and renewal registrations with state Boards of Pharmacy and tissue banking regulators, and various federal medical device and tissue banking establishment registrations The RA department's is also responsible for compliance with company financial budget and personnel performance and efficiencies. As well as the timeliness of performance registrations and renewals, and avoidance of penalties for tardy or late submissions. The ideal candidate must live in Birmingham, Al.
The responsibilities of this position include, but may not be limited to the following :
- Maintaining FDA establishment registrations, and medical device listings
- Ensure compliance with states Board of Pharmacy and tissue banking regulations and medical device.
- Acting as regulatory liaison for the entire product lifecycle for dental implants, tools and accessories
- Participating, as directed, in product registration activities for US FDA, European and other international markets.
- Participating, as directed, in product complaint investigation activities and support overall complaint management.
- Maintenance of company product registrations data for global markets as directed.
- Assisting in the authoring of regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
- Review labeling, training, promotional and advertising material, as directed by supervisor.
- Providing support to regulatory affairs operations and administrative requirements
- Other duties as assigned.
The ideal candidate for this position will possess the following qualifications :
Benefits :
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen .