Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
Serves as a senior strategic consultant and subject matter expert for client services. Key liaison between clients and regulatory bodies in matters of policy. Works independently as well as in collaboration with Business Development to identify and solicit potential clients. Develops internal training programs and/or mentors junior RCRI staff.
DESCRIPTION OF RESPONSIBILITIES & AUTHORITIES:
· Provides leadership as a project advisor internally to RCRI teams and as a project director externally to clients.
· Serves as a senior, strategic consultant to RCRI clients and RCRI staff.
· Acts as a liaison between clients and regulatory agencies in matters of policy interpretation and implementation.
· Serves as a subject matter expert.
· Provides internal guidance to ensure that departmental services meet industry expectations, and governmental regulations.
· Interacts with clients and potential clients throughout all levels of industry and corporate management.
· Identifies and solicits potential clients.
· Represents RCRI to outside industry affiliations and organizations.
· Actively works and maintains industry contacts and professional network.
· Mentors staff in topics for which they are a subject matter expert.
· Represents and assists in the marketing of RCRI capabilities and services to potential and current clients through marketing meetings, presentations, attending pertinent trade shows, seminars, conferences, etc.
· Develops and conducts internal (RCRI) training in areas of expertise.
MINIMUM POSITION QUALIFICATION REQUIREMENTS:
· Advanced degree in a scientific or technical field is required. Professional certification (i.e. RAC) desirable. Experience of at least 15 years in a regulatory affairs capacity in lieu of the advanced degree will be considered.
· Minimum of twelve years of experience in medical device companies.
· History of cooperative working relationships with regulatory agencies or scientific associations/committees desired.
· Expertise in more than one area of RCRI services is highly desirable.
· Must have demonstrated proficiency in area of expertise by publishing, lecturing, serving on expert committees, or by work history.
· Demonstrates a professional demeanor that promotes superior work performance.
· Superior oral and written communication skills; must feel comfortable writing, speaking and presenting to a variety of audiences
· Effective interpersonal skills.
· Strong organizational skills and detail-orientation.
· Demonstrated abilities to communicate cross-functionally throughout organizations.
· Familiarity with basic computer applications, e.g., Word, PowerPoint.
· Ability to travel up to 25% of the time.
Telecommuting is allowed.
Internal Number: Sr Reg PA 2019
RCRI is a leading provider of strategic consulting and integrated clinical trial services to the medical device, IVD, biologics, and combination product industries. Services include Clinical Research, Regulatory and Quality Systems, Health Economics & Reimbursement, and Compliance.
For more than two decades, RCRI has been turning medical product concepts into successful, revenue-generating businesses for clients worldwide. We look at every angle of the project entrusted to us, offering the value of our combined experience, insight and foresight to create comprehensive interdisciplinary solutions. By creating a collaborative partnership with our clients, we achieve great results together.