Director Regulatory and Clinical
Manage day to day activities for Regulatory Affairs function. Partner with internal departments and external consultants to efficiently deliver accurate, timely, and effective regulatory documents, deliverables and other projects in line with company policies and procedures. Provide regulatory guidance with various ongoing cross-functional projects to remain in compliance with all FDA and other U.S. and international regulatory requirements. Responsible for strategic leadership relative to design of clinical studies and interpretation of established literature and TRUVIC clinical data. Interacts with both internal and external customers to facilitate clinical programs. May select, develop, and evaluate personnel to ensure effective support of TRUVIC clinical programs. This position contributes to and supports the company’s research and development efforts to create high value medical devices to address unmet clinical needs. Manage aspects of clinical operations for early feasibility and other studies. This includes operational leadership relative to planning and executing clinical studies and overseeing data collection and monitoring activities.
Essential duties and responsibilities
Other duties may be assigned on an individual basis:
- Partner withSenior Management to define and execute on the company’s regulatory strategy and priorities.
- Key contact for FDA and Notified Body submissions and onsite audit management.
- Prepare regulatory filings such as 510(k), IDE, PMA, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines.
- RepresentRegulatory discipline in Project Teams to ensure timelines and resource allocations are factored into deliverables.
- Develop global regulatory strategies for various projects.
- Prepare various presentations to regulatory agency reviewers and/or inspectors as needed.
- Review and approveDocuments Change Order requests, CAPA’s, NCMR’s, etc.
- Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols.
- Manage coordination of international product registrations and licensing documentation
- Act as regulatory representative on project teams to ensure timeliness and resource allocations are factored into deliverables.
- Provide strategic leadership and design input for clinical studies including interacting with KeyOpinion Leaders on clinical study designs and protocols. Prepare critical data for physicians and proposals. Perform risk analysis of protocols with investigator and internal stakeholder input
- Research, review, analyze, and interpret literature and apply to clinical trial designs and develop proposals to regulatory agencies.
- Develop/edit/approve protocols, case report forms, and database specifications, and statistical plans.
- Recruit investigators /study sites and negotiate support levels. Manage clinical trial agreements and internal and external review process
- Review Regulatory documentation for completeness and accuracy during study initiation and maintain such documentation throughout the study
- Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH guidelines, HIPAA, trial registration, and all other applicable regulatory guidelines
- Review, analyze, and interpret clinical trial data. Prepare and maintain Clinical Evidence Reports. Manage internal and external clinical statistical analyses to meet objectives
- Ensure appropriate regulatory controls (site and patient) are in place for all study activities
- Serve as a scientific and clinical resource and adviser within TRUVIC including providing guidance toClinical Trials Management, Regulatory, R&D, and Project Management staff
- Part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical IDE sections
- Prepare presentations for scientific conferences, investigator meetings, and expert advisory meetings
- Develop and review scientific publications
- Assist in clinical evaluation of business development opportunities
- Evaluate and manage investigator-initiated research proposals
- Develop project budgets and control expenditures within limitations of department and project budgets.
- Actively promote and support the Quality Management System, Quality Objectives, Quality Policy and ManagementReview process.
- Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicableFDA and Regulatory requirements.
- Inform responsible personnel of concerns involving product quality.
- Perform job functions in a safe and effective manner.
- Other duties as assigned.
Education / experience
- Bachelor’s degree in are lated field and 10+ years’ experience in healthcare-related industries, including 5 or more years’ experience in the medical device industry
- Master’s degree (MBA, MSN,MS) or Doctorate highly desirable
- Expertise with MDRs, IDEs,PMAs and 510(k) filings
- Extensive knowledge of FDA requirements, hospital, and health care environments
- Strong knowledge of GCPs
- 5+ years’ experience indirect management of clinical teams required
- Excellent written and verbal communication skills required; technical writing capabilities are a must
- Experience interacting with physicians, clinicians, and patients
- A proven decision maker, hands-on and action-oriented style must be evident
- Prior management training and experience is desired
- RAC certification a plus
- Proven ability to manage a team of regulatory professionals and prioritize multiple projects independently
- Demonstrated success in developing complex clinical affairs strategies across multiple product lines across multiple multi-national geographies
- Must be willing to travel 20 - 30%
- May supervise contract RA resources, and RA team members as in-house staff grows
- Managerial responsibility for subordinate clinical staff
* Work includes potential exposure to human blood borne pathogens or other potentially infectious materials.
* Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
* Work includes potential exposure to chemicals