Director of Regulatory and Clinical Affairs

Director of Regulatory and Clinical Affairs

Bannick LLC is a well-established and respected medical device consulting organization. Bannick consists of a network of subject matter experts who are passionately engaged in the medical device industry and thrive in their contribution to the health and safety of patients around the world. Bannick’s consulting expertise includes Regulatory, Clinical Research, Quality Systems, Professional Writing (including FDA submissions) and Reimbursement services.

Bannick is poised for significant growth over the next five years. The Director of Regulatory and Clinical Affairs is a key leadership position spear heading the development and execution of regulatory and clinical affairs. This role provides overall program leadership and management and ensures cross-functional alignment. This position partners closely with clients to identify risks, resolve issues and ensure on time service delivery.

This is an incredible opportunity to work with a wide variety of medical technologies for clients ranging from early stages to established, prominent international companies.  This is a full-time, permanent and remote position with competitive compensation, paid time off, medical benefits, 401K, and more.

Responsibilities:

• Lead and manage the Regulatory Affairs/Clinical Affairs including client development and employee recruitment, training and development.
• Regulatory Affairs
  • Lead regulatory affairs projects, including client proposals, strategy development, interaction with clients and regulatory agencies, submission development and execution.
  • Manage regulatory contracts to ensure a highly professional and complete work product and on time service delivery.
  • Build Bannick’s regulatory business and profitability of the department.
• Clinical Affairs
  • Lead all clinical study projects, including client proposals, strategy development, and interaction with clients. Collaborate with internal leaders to determine resources for study operations and execution, including data management, monitoring and electronic data capture.
  • Manage clinical contracts to ensure a highly professional and complete work product and on time service delivery.
  • Build clinical business and profitability.
• General Management
  • Plan and facilitate meetings and working sessions to gather information, ideas and insights, develop recommendations, and build alignment for execution.
• Business development:
  • Network outside the organization to promote all aspects of the business.

Qualifications:

• Advanced Degree in biological or medical science. Equivalent education and experience with demonstrated ability to perform the essential functions of the job may be considered.
• Minimum 15 years’ experience with clinical evaluation within the medical device industry.
• Expertise with current regulatory agency guidance and regulations, including EU MDR and MEDDEV Rev 4, ISO 13485 and 14971, FD&C Act, FDA 21 CFR 11, 812, 814, and 820, 510(k) regulations, and GCP and GMP.
• Demonstrated ability to critique clinical, regulatory, and quality documentation.
• Excellent communication and interpersonal skills, with a proven track record of establishing and maintaining effective communication with colleagues and clients.
• Clear expert knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states.
• Proven reputation for working strategically to achieve client and company goals.
• Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel, EndNote or comparable citation manager, and PerfectIt software).
• Demonstrated excellence in time management.
• Proven success in meeting client needs and leading initiatives and teams while operating in a remote/geographically diverse organization.

Qualified candidates please send resumes to swyatt@Talencio.com

No recruiters, please.