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Senior Director, Regulatory Affairs

Company: BioHorizons Implant Systems
Location: Birmingham
Posted on: September 15, 2020

Job Description:

RAPS Regulatory Affairs Certification (US) desired. AATB Certified Tissue Bank Specialist desired

Senior Director Compliance Office Jobs in Birmingham, AL. TheSenior Director, Regulatory Affairs strongly influences organizational business performance by maintaining compliance with domestic and international quality system and product registrations, and through support of other functional departments or product sales staff and distributors in supplying quality and regulatory input and feedback. Performance in the execution of responsibilities directly influences supplier and customer (including regulators) perceptions of BioHorizons ability to meet expectations and requirements.. The responsibilities of this position include, but may not be limited to the following:. Developing and maintaining quality and regulatory systems and system elements in conformity with domestic and international medical device agency regulations and requirements. System elements include product labeling and sterility assurance. Submitting domestic and international quality and regulatory system and product registrations in the manner prescribed by the applicable medical device agency. Communicating with domestic and international suppliers, sales agents or distributors, and regulatory medical device agencies in an appropriate manner as circumstances require. This includes Quality System Management. Representative responsibility for interaction with regulatory agencies in the absence of the SVP QA/RA, and also includes customer complaint administration with reporting to regulators and internal company management in compliance with medical device regulations and company policy. Advising company management of quality and regulatory compliance requirements that affect other functional areas, and assisting those managers in meeting the required objectives. Supervising personnel assigned to Regulatory functions in a manner appropriate to their responsibilities, and in compliance with employment law and company policies. The Sr. Director, RA may take all reasonable and prudent steps necessary to maintain compliance with company and product registration requirements, with appropriate notification to, and/or direction from, the SVP, QA/RA. Manage Regulatory Affairs team. Other duties as assigned. The ideal candidate for this position will possess the following qualifications:. Bachelor’s Degree required. Master’s Degree preferred. Ten years increasing responsibility experience as a quality or regulatory engineer, supervisor, or manager in a medical-device manufacturing environment required; manager or senior manager (Director-level or above) experience desired.. Experience as a regulatory team member participating on at least ten (10) FDA 510(k) submissions required, with submission lead experience for at least three (3) submissions; OR, experience as a regulatory team member for three (3) FDA PMA submissions. A combination of experience with 510(k)s and PMAs is acceptable if the minimum requirement for one or the other is lacking. ASQ certification (e.g., Quality Manager, Engineer, Auditor, etc.) desired. Strong attention to detail required. Excellent organizational, interpersonal, written, and verbal skills. Demonstrated problem-solving skills. Must have the ability to work and communicate effectively with others. Experience with MS Office suite required. 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.. Get alerts to jobs like this, to your inbox.

Keywords: BioHorizons Implant Systems, Birmingham , Senior Director, Regulatory Affairs, Other , Birmingham, Alabama

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