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Regulatory Affairs Associate III

Biohorizons Implant Systems
Birmingham, AL
  • Expired: February 20, 2021. Applications are no longer accepted.

The Regulatory Affairs Associate III can heavily influence the Company's compliance with product registration requirements in domestic and international markets. The compliancy with Quality System Regulations and standards with respect to following     Good Manufacturing Practice and Good Documentation Practice. The RA III has the authority to clear or disallow product shipments to affected international markets based on product approval and/or registration status. To train/mentor staff in all areas of Regulatory Affairs and medical device business fundamentals and provide direction to the business as necessary with regard to applicable U.S. and international regulations.

 

Essential Duties and Responsibilities:

 

  • Initiate and maintain medical device product registrations globally, focusing on international markets
  • Works directly with subsidiary office personnel and distributors to provide direction and assistance in all matters of BioHorizons product legal/regulatory compliance, registrations and availability in international markets.
  • Management and daily administration of international order system to ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.
  • Mentor junior Regulatory Affairs personnel on international market regulatory activities 
  • Document, release and communicate to stakeholders, internal and external of changes to regulatory affairs policies and procedures.
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Assist in the development of regional regulatory strategy
  • Determine trade issues to anticipate regulatory obstacle
  • Determine and communicate submission and approval requirements
  • Participate in risk benefit analysis for regulatory compliance
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing
  • Compile, prepare, review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies
  • Monitor applications under regulatory review
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts
  • Assist with label and IFU development and review for compliance before release
  • Ability to manage multiple establishment and product registration activities
  • Submit and review change controls to determine the level of change and consequent submission requirements
  • Provide regulatory input for product recalls and recall communications
  • Other duties as assigned

 

Qualifications:

 

  • 6-8 years minimum experience in a medical device (U.S. FDA-regulated and registered) Manufacturer or Specification Developer in the U.S. and/or foreign regulatory submissions required.
  • Experience with FDA pre-market submissions (Q-Sub, 510(k), etc.) preferred.
  • Complaints Management, MDR Reporting, CAPA administration, Auditing experience preferred.

 

Education and Experience:

 

  • Bachelor's Degree required, STEM degree preferred
  • Graduate degree prefered (Science, Business, Regulatory Affairs) 
  • Extensive experience in Regulatory Affairs may compensate for formal college/university education.
  • Regulatory Affairs Professional Society (RAPS) Certification (US)  prefered, but not required.
  • ASQ certification (e.g., Quality Manager, Engineer, Auditor, etc.) prefered, but not required

 

 

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.

 

Biohorizons Implant Systems

Address

Birmingham, AL
35244 USA

Industry

Government

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