Vice President of Regulatory Affairs & Quality Assurance
Publicly held, well financed and poised for sustained growth, our client develops and manufactures automated Molecular Diagnostics systems and tests for clinical diagnostics markets. Having successfully introduced FDA-cleared molecular diagnostics tests based on their proven direct detection technology, the Company is now focused on development and commercialization of next generation rapid, automated sample-to-result, random access multiplex clinical tests and instruments. The novel rapid diagnostics tests they are developing, together with their automated testing platform, will provide low cost and complexity, on demand, rapid solutions for the molecular diagnostics market. With multiple assay development teams and a strong pipeline of new products, the company is well positioned for rapid growth through menu expansion. The Company is developing international distribution channels and is prepared to enter global markets in 2011.
The Company has fully integrated commercial operations and offers an open, collegial, entrepreneurial working environment.
The VP of Regulatory Affairs and Quality Assurance is a key member of the senior management team and reports to the CEO.
The Vice President of Regulatory Affairs & Quality Assurance has overall responsibility for leading all aspects of global regulatory affairs, clinical affairs and quality systems for the business. Specific responsibilities include managing all aspects of regulatory and quality strategy development and implementation and communicating directly with global regulatory agencies (U.S. FDA, Health Canada, EU, ISO, Japan MHW, etc) on all regulatory matters. This includes preparing and submitting product submissions for regulatory agency clearance and approval, designing and executing clinical studies used to support product submissions, overseeing all aspects of the implemented quality management system and leading all U.S. FDA and ISO facility inspections. In addition to providing leadership to the regulatory affairs, clinical affairs, and quality assurance departments, the Vice President of RA & QA will provide guidance to new product development teams and manufacturing groups and collaborate closely with other Executive Team Members to define the strategic direction of the organization and to drive business growth.
- Serve as the key contact for regulatory agency, notified body, and customer audits of the facility
- Develop and implement efficient and effective regulatory strategies to bring products to market (domestic and international).
- Develop and implement strategies for educating the FDA on various aspects of the technology and scientific principles upon which the product system operates.
- Maintain excellent relationships with regulatory agencies, subcontractors, and providers of non-clinical and clinical studies
- Prepare and submit marketing approval applications (510(k)s, PMAs, CE Product Certifications, Design Dossiers, International Licenses, etc.)
- Oversee and assist in the review and approvals of product packaging and labeling and Sales and Marketing promotional materials.
- Identify relevant quality standards for product development and manufacturing and defining design requirements for domestic and international markets.
- Ensure the company is in full compliance with regulatory agencies
- Promote the development of a facility-wide understanding of the key elements related to quality system and regulatory compliance requirements.
- Effectively lead and manage department regulatory and quality personnel.
- As a member of the senior management team, provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
Candidates should posses the following experience, abilities and attributes:
- 5 to 10 years experience in clinical in vitro diagnostic regulations, including successful pre-market submissions for domestic and international markets. Experience with molecular diagnostic submissions a plus.
- Demonstrated success related to development and implementation of pre-clinical and clinical strategies for clinical in vitro diagnostics, implementation of facility regulatory and quality systems, and assuring compliance to all applicable regulations.
- Strong technical background in devices/applications highly desirable. Ability to think ‘out of the box’ and create novel solutions to challenging problems is an absolute necessity. The successful candidate must work well in team settings and also be able to work independently to ensure completion of time critical projects.
- Minimum of BS degree in scientific discipline, preferably life sciences, biomedical, or other engineering science. MS or PhD a plus; auditor qualifications a plus.
- Previous supervisory or team leadership experience
- Proven track record of clinical study oversight and management; demonstrated record of managing collaborators and projects; demonstrated record of working on project teams and multitasking
- Authoritative knowledge of current US and international in vitro clinical diagnostic regulations and guidelines.
- Excellent interpersonal and leadership skills; self-motivated and flexible to changing schedules.
- Strong attention to detail, good oral and written communication skills
- Strong computer skills, including word processing, spreadsheet and data programs.
DESIRED QUALITIES & DELIVERABLES
The Company is seeking an IVD Regulatory & Quality Assurance Executive with the technical expertise, regulatory knowledge, and passion to drive their product approval & commercialization efforts.
- The ideal candidate will be a well organized, creative, strategic thinker equally capable of tactical execution and driving results, as well as articulating unique ideas and perspectives.
- The successful candidate will have the presence and integrity to command respect and the confidence and energy to be an effective change agent. They will have an appreciation of and sensitivity to bridging scientific research with marketplace realities and the knowledge and facility to establish business relationships that will optimize the company’s commercialization opportunities.
- The company is seeking an individual who can develop plans and processes that emphasize acceleration of development cycles & optimization of product development, as well as the leadership skills to effectively implement.
The complete package will include a competitive base salary, a performance-driven bonus program, significant stock options and restricted share grants, a highly attractive benefits program, and relocation.
Mr. Larry Glines
39 South LaSalle Street, Suite 714
Chicago, IL 60603