Director Clinical and Regulatory Affairs

Company: Randstad USA
Location: Farmington
Posted on: May 15, 2022

Job Description:

job summary: Seeking an experienced clinical and regulatory leader to guide and support our clinical collaborations and regulatory approval strategy. This person will provide senior level leadership of the company's existing and planned clinical collaborations and studies, and will provide strategic direction for the company's regulatory activities to ensure alignment of clinical activities and regulatory strategy, resulting in successful market introduction of the company's products. This position is a key member of the senior management team, reporting to the CEO with exposure to the Board of Directors. Requirements:

• Minimum of 5 years of clinical trial leadership experience, with 3+ years of managerial experience, in a medical device environment.
• Track record of participating in taking products through U.S. FDA Pre-Market Application (PMA) and 510(k) clearance. Knowledge of EU MDR is a plus.
• In-depth understanding of medical device product development processes and the requirements of FDA 21 CFR Part 820 and ISO 13485.
• Thorough understanding of Good Clinical Practices and clinical operations best practices
• Bachelor's degree (Master's or higher preferred) in a Life Sciences or similar field; or equivalent experience
• Track record of KOL engagement and engagement with therapeutically relevant organizations and advocacy groups
• Experience managing CROs and vendors throughout entire clinical trial life cycle
• Understanding of biostatistical concepts and is adept at reviewing data analyses
• Proven success participating in cross-departmental teams (senior management, engineering, QA, program management, finance, business development, scientific affairs, medical writing)
• Proven success in leading and coordinating cross-functional clinical trial teams (e.g., clinical operations, data management, biostats, clinical supply chain)
• Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections
• Experience with employee development (e.g. coaching, mentoring), talent acquisition, performance management, conflict resolution and providing work direction to teams
• Excellent verbal and written communication skills are essential.
• Experience in a start-up is a plus. - location: Farmington, Connecticut job type: Permanent salary: $150,000 - 200,000 per year work hours: 8am to 5pm education: Bachelors - responsibilities: Responsibilities:
  • Leads organizational understanding of the current clinical landscape, developing the clinical evidence strategies to best position the company for successful regulatory approvals and commercialization.
  • Provides senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and agency precedent to the Company's product roadmap.
  • Designs and leads execution of clinical studies for regulatory submissions, reimbursement, and market adoption, including clinical study documents (protocol, case report forms, investigator brochures, clinical study reports, etc.), study implementation and data reporting activities.
  • Fosters and maintains strong relationships through direct interactions with medical advisors, KOLs, clinical leaders and study investigators and their staff.
  • Assists CFO in contract and budget negotiations with hospitals, consultants, investigators, CROs, database management firms and outside vendors.
  • Works closely with product development team to define product requirements and obtain user feedback through KOL and clinical team interactions.
  • Responsible for administrative activities associated with the clinical department including procedures (SOPs), training of key personnel and preparation and maintenance of objectives and budgets.
  • Oversees quality review and analysis of clinical data.
  • Creates the publication strategy, leads abstract and manuscript writing and submission activities as well as training efforts to understand and interpret available clinical evidence
  • Contributes to writing and review of clinical documents in regulatory agency submissions (IDE, PMA, MDR, etc).
  • Ensures that clinical trials are properly resourced, managed and executed in accordance with protocols, timelines and good quality practices.
  • Implements best practices and standards for trial management in collaboration with other members of the team
  • Lead initiatives to build departmental infrastructure. - qualifications:
    • Experience level: Experienced
    • Minimum 10 years of experience
    • Education: Bachelors - skills:
    • Regulatory Affairs / Compliance Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Keywords: Randstad USA, Farmington , Director Clinical and Regulatory Affairs, Executive , Farmington, New Mexico