Title: Director of Quality Affairs
Summary: The director is responsible for the creation, strategic implementation and maintenance of the quality system and processes, in compliance with international and United States federal laws. The director will correspond with Food and Drug Administration and European Union notified bodies as a representative of the company during the preparation and submission of applications for regulatory approval for both new medical products and changes to existing products. This a leadership position reporting directly to the company President for all performance measures for quality improvement and compliance necessary to support the company operations within the regulatory guidelines.
Specifically, the director must ensure company compliance with global regulations for design controls, good manufacturing processes, facility registration, device listing, licenses, safety reporting, complaints, clinical trial requirements, post-market surveillance, product labeling, and permissible marketing communication. The regulatory strategies are expected to improve the scientific or technical direction of product design and/or development in a cost effective manner with minimal administrative burdon.
The director will provide leadership and subject matter expertise in global regulatory affairs to ensure functional excellence and is responsible for both internal and external quality control. He or she will interact with global health authorities and establish collaborative relationships with other key influencers. The director should be persuasive and promote a positive working environment conducive to a productive team atmosphere.
Company Overview: Hibernicor, LLC is an innovative company responsible for designing, manufacturing, assembling, packaging, processing and labeling medical devices and software. Asporto is Hibernicor’s signature product that allows for the improved and prolonged preservation of the donor heart. Asporto will be marketed for initially for sale in the US and Europe.
Key Responsiblities:
The Director of Quality Affairs will work closely with marketing efforts, research and development, and manufacturing, to develop the regulatory strategy to gain market approval for Asporto as well as other new or modified devices/combination products consistent with company objectives.
The director will interpret national and international regulatory requirements and manage resources needed to support and execute proactive strategies needed to further the global growth of the business. He or she will lead the preparation, submission, and defense of complex regulatory applications including: premarket approvals (PMA), new drug application (NDA), biologic license applications (BLA), pre-market notification (510k), investigative device application (IDA), combination devices, Notified Body/Competent Authority applications, Health Canada licenses, and submissions to other international health authorities.
The director will also review and interpret regulatory rules as they relate to internal company products and processes. Importantly, the directory will develop quality system policies and procedures to ensure compliance with FDA 21 CFR, Part 820, Quality System Regulation and EU requirements as well as any other regulatory markets. Specifically, the director will guide product development teams in developing new products in accordance with design control, define needed quality metrics, and coordinate data collection from various functions with simplified and efficient document control processes. The director will coordinate and consult in a positive and friendly manner with company stakeholders regarding the quality, content, format, and assembly of regulatory documentation. The director will also ensure subcontractors meet regulatory compliance requirements and are approved by regulatory affairs at the initiation stage.
The director will represent Hibernicor as the official correspondent with external organizations including the FDA and other global health authorities, sponsors, and other organizations; serve as a primary regulatory contact and correspondent during all pre-market activities and monitor Hibernicor supplier’s performance to support the regulatory approval and commercialization efforts in global markets. Specifically, the director will ensure all periodic national and international regulatory registrations or filings, licenses, listing, and other certifications are maintained to established timelines as required for regulatory compliance and company objectives.
The director will perform periodic audits and advise management of any nonconforming material or process related issues and make recommendations for improvements or administrative disposition. She or he will set-up and oversee inspection and device dossier activities, manage internal audit activities and coordinate corrective actions. Any change notifications will be evaluated and submitted regulatory bodies as needed. The director will manage the safety reporting and complaint handling processes to ensure corrective actions are established and that root-cause elimination are completed for all identified issues.
The director will ensure preclincial and clinical studies are designed and executed in full compliance to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), ICH, and other pertinent global regulations.
The director should possess in-depth understanding and will actively review evolving laws/regulatory requirements to maintain a proficiency in worldwide regulations and will proactively communicates pertinent information to the company leadership in written and oral presentations. The director will personally conduct ongoing company-wide trainings on FDA and ISO requirements in a clear and concise manner. The director will ensure all employees within the assigned teams understand and comply with all applicable company policies and procedures as well as local, state and federal laws and regulations. In regards to advertising and promotional literature the director will assist marketing efforts by providing examples for product labeling and promotional materials.
The director may interpret and provide recommendations for change of company-wide policies and practices, as well as developing written policies appropriate for the company operations and goals. The director will regularly interact with industry executives, senior management, and major customers. These interactions frequently will require negotiation skills to influencing customers and/or senior level leaders in matters of significance to organizational quality. The director is an internal expert resource to provide regulatory consultation in respect to company’s strategic goals. The director may assist with other duties such as hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations. The director may also provide leadership guidance, and coaching to maintain an engaged and productive workforce.
Qualifications:
Master’s degree in a life sciences or biomedical engineering fields, fluent native command of written and spoken English language,
Minimum of 10 years of quality management, quality assurance and regulatory affairs experience in the medical device, pharmaceutical, biotechnology, contract research, or similarly regulated industry.
Regulatory Affairs Certification (RAC)
Demonstrated ability to write technical documents and persuasive presentations to competent authorities.
Encyclopedic knowledge of FDA, QSR and ISO standards, regulations and requirements.
Reporting: The Director of Quality Affairs reports directly to the company president.
Location: The location of the job is at the company offices either in the US or UK. If travel is necessary to accomplish the job responsibilities it is anticipated to be no more than 10% of the employment time.
Type of Employment: The position is full time.
Salary Range & Benefits: The salary and benefits are commensurate with the applicant’s qualifications and experience.
Direct Inquiries, Cover Letter, References, and Resume to:
Dr. Andrew L. Rivard
President and Founder
HIBERNICOR LLC
253 Ridge Drive
Jackson, MS 39216
Office: 769-257-6146
Email: