Regulatory Affairs Associate I

4 weeks ago

Hoover, United States BioHorizons Full time

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:

  • 4 year undergraduate degree required with a degree in the sciences preferred.
  • Equivalent experience in regulatory affairs with medical devices, IVDs or human/animal tissues will be considered. Basic knowledge of regulatory concepts and QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with knowledge of design and change controls.
  • Up to three (0-3) years experience in a medical device or other similarly regulated industry with establishment or product registration experience preferred; U.S. FDA and international regulatory product submissions experience desired.
  • Experience with previous quality management system desired with medical device or human tissue banking.

Benefits:

  • 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
  • Flexible Spending Account or HSA Account available
  • Vision Benefits
  • Company paid Dental Insurance for employee and dependents
  • Wellness Plan
  • 401k with 5% matching
  • Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
  • Company paid Short Term Disability
  • Long Term Disability
  • Company provided Life Insurance
  • Paid Parental Leave
  • Casual Dress Code
  • Social events for employees and family

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.

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