Senior Director, Regulatory Affairs
Company: BioHorizons Implant Systems
Posted on: September 15, 2020
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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