2 Director of Regulatory Affairs Jobs in West Lafayette, IN
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Cook Group is Hiring a Director of Regulatory Affairs Near West Lafayette, IN
- 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
- 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
- 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
- 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
- Encourage team to identify and implement improvements to regulatory processes
- Identify and experiment with new regulatory schemes to get products approved
- 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
Job Summary
Full Time
Wholesale
$142k-189k (estimate)
01/27/2023
04/03/2024
cooksf.com
OAKLAND, CA
25 - 50
2006
Private
NONA LIM
$10M - $50M
Wholesale
Related Companies
About Cook Group
Cook! makes gluten-free eating tasty, easy, and healthy and also offer gluten-free meals delivery and dairy-free entrees.
The following is the career advancement route for Director of Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Director of Regulatory Affairs, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director of Regulatory Affairs. You can explore the career advancement for a Director of Regulatory Affairs below and select your interested title to get hiring information.
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