The Director of Regulatory Affairs provides the primary management function, leadership, and direction for regulatory affairs across Cook Biotech. Provides strategy for maneuvering regulatory pathways to enable regulatory approvals in targeted countries or regions. Is the primary regulatory Cook Biotech contact to interface with regulatory agencies world-wide. Manages the personnel needs for the... department including managers, scientists, engineers, attorneys, specialists, and consultants. Provides cross-functional co-ordination with other Cook Biotech departments. Provides training and development for department employees. Writes, reviews and approves documents for submission to regulatory agencies and Cook Biotech Quality System.

Responsibilities

Personnel
• Provide leadership to the Regulatory Affairs team with attention to corporate goals, policies, procedures and the Quality System. Such leadership will include training, evaluating, scheduling, and directing
• As needed, build a team of external resources to enhance team capabilities
• Set team initiatives, building consensus and buy-in for metrics, monthly and quarterly goals, and yearly and strategic initiatives
• Develops and motivates the regulatory staff to handle increasing work complexity
• Must be able to inspire and develop people to become more than what they thought they could be

Areas of Responsibility
• Department leader and mentor
• Regulatory strategy and execution
• Facilitates prioritization of regulatory projects
• The face of Cook Biotech to regulatory bodies
• Permanent member of QMRB, consultant for Officers

Decision-Making
• Able to integrate a wide array of technical inputs with regulatory and legal requirements
• Capable of applying risk analysis to any situation
• Able to balance regulatory requirements with business needs to find the optimum path forward in getting products through the regulatory review process

Collaboration/Communication
• Communicate the face of the regulator to Cook Biotech
• Communicate the face of Cook Biotech to the regulator
• Effectively communicate with all company stakeholders to manage project priorities and resolve any conflicts
• Interface across all departments to assure the availability of required technical data for submission purposes
• Interface across all departments to assure that everyone understands the technical requirements for compliance
• Write and speak convincingly to a technical audience and instill confidence in the minds of the reviewers
• Must be able to know the history of ECM technology in sufficient detail to avoid unnecessary testing and be able to use this knowledge to educate reviewers

Change/Innovation
• Encourage team to identify and implement improvements to regulatory processes
• Identify and experiment with new regulatory schemes to get products approved

Qualifications
• Bachelor’s degree in Engineering or Science with extensive experience in regulatory affairs (Master’s or PhD degree preferred)
• Four or more years in Regulatory Affairs of medical devices
• RAC certified
• Superior speaking and writing skills
• Proven leadership skills
• Proven ability to effectively communicate and collaborate with other leaders and project stakeholders
• Proven project management skills
• Proven ability to train others
• Intimate knowledge of US and EU regulatory requirements
• Superior scientific logic and analytical skills
• Intimate knowledge of extracellular matrix technology and their regulatory approvals/clearances
• Understanding of requirements from FDA CDRH and CBER branches
• Familiarity with many scientific areas, including: Chemistry, Physics, Chemical Processing, Biology, Microbiology, and Statistics

Physical Requirements
• Travel as needed (mostly domestic travel)
• Physical demands typical of an office or classroom
West Lafayette IN USA

Salary Criteria