C2N Diagnostics, a biotech company actively involved in developing diagnostics for neurological disorders, is looking for a qualified VP of Regulatory & Quality Assurance. The VP will lead the global Regulatory and QA function and develop regulatory strategies for new product development and registration as well as life cycle management of current lab-developed tests. The VP will manage the strategy and interactions with a full range of regulatory authorities in US as well as international markets through leadership of a small US-based regulatory team and outside experts in international regions. From time to time, the VP will also interact with third-party collaborators (e.g., international or regional distributors and/or partner reference laboratories) to assist in coordination of international regulatory activities, as applicable. The VP also will be responsible for leading the Quality Assurance function and ensuring overall compliance necessary for successful business operations as well as planning, executing, and directing policies, programs, and initiatives and serving as C2N’s chief spokesperson with various regulatory agencies. This position is remote with occasional travel. Midwest-based candidates are preferred.

C2N is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status, veteran status, marital or parental status, pregnancy, citizenship status, sexual orientation, gender identity and/or expression or any other characteristic protected by law.

The VP of Regulatory & Quality Assurance will be responsible for:

Serving as an internal expert on relevant global regulations and guidelines
Managing the quality initiative of C2N to comply with FDA GxP Regulations and EMEA guidelines, etc. as appropriate
Developing and implementing the worldwide regulatory and QA strategy
Coordinating the preparation, submission and follow-up contact with regulatory agencies and having lead responsibility for regulatory review and final approval for all submissions and associated documentation
Tracking regulatory and QA trends and requirements in the global markets and identifying the potential impact on C2N and recommending the most effective path to regulatory approval for C2N’s products
Acting as the primary spokesperson for C2N with external organizations through direct communication with regulatory authorities
Coordinating interactions with global regulatory agencies to support registrations and filings
As applicable, working with third-party collaborators (e.g., international or regional distributors and/or partner reference laboratories) to assist in coordination of international regulatory activities, as applicable
Reviewing and providing approval on marketing and sales materials
Developing, communicating and maintaining project schedules for regulatory filings that are consistent with product development and commercialization plans
Contributing to the development of best-in-class processes and Standard Operating Procedures (SOPs) to ensure regulatory compliance
Managing all quality policies and procedures to maintain a high level of regulatory compliance
Reviewing and updating SOPs and related documents
Directing and managing the quality assurance group and consultants
Managing all client audits and regulatory agency inspections as well as formal responses to their findings/recommendations as required to maintain high level of compliance
Developing a vendor qualification program and ensure all vendors have been qualified based on vendor qualification program
Participating in management and project teams as necessary

Qualified Candidates will possess the following qualifications:

PharmD, PhD/MD preferred with 15+ years' experience in managing regulatory process and registration aspects of medical devices
Strong knowledge and experience working with FDA CDRH / IVD US regulations and European Union In Vitro Diagnostic Medical Devices (IVDR) Regulations
Strong audit background, knowledge of quality improvement initiatives and risk management principles
Extensive experience with quality systems including CAPA, change control, deviations, and investigations
Extensive experience successfully interfacing with regulatory agencies, both foreign and domestic
Experience with supporting regulatory filings and managing regulatory inspections of medical devices
Ability to partner closely with senior leaders, cross functional teams within R&D and Commercial Operations, to develop regulatory strategies in close alignment with business objectives

Physical Requirements:

Ability to sit and stand for up to periods of four (4) hours
Ability to lift up to thirty (30) pounds in an office environment

C2N Diagnostics

New Jobs

VP of Regulatory & Quality Assurance