The Director, Regulatory Compliance is a key member of the Quality Management Team with responsibility for an operating budget and Strategy, and reports to the Vice President of Quality, Regulatory Affairs and Tissue Services. The Director, Regulatory Compliance is responsible for providing company leadership in the areas of global Medical Device, Human Tissue and Drug Regulations and Standards. The incumbent will establish strategies to assure Quality Systems are appropriate and followed throughout LifeCell and its strategic partners and vendors.
Specific responsibilities of this position impact the compliance and financial results of the organization by: 1) ensuring global compliance in areas of standards and regulations 2) understanding global regulation and standard changes to drive strategy and continuous improvement, 3) understanding LifeCell business strategy to translate growth and complexity into scalable, efficient, and compliant programs, and 4) establishing strong assessment processes to identify areas of compliance improvement.
The position is also responsible for direct staff performance, development, and project execution, budget management and setting/driving overall Quality organizational goals.
Establish a Compliance program that includes internal assessments to determine areas of strength as well as opportunities for improvement.
Carry out duties as a senior leader within the LifeCell Quality organization to insure Compliance requirements are met. Act as a leader and mentor to all Quality and Compliance employees.
Monitor and implement processes to insure compliance with regulations and guidelines, including but not limited to FDA 21CFR 1271 and 820, ISO 9001 and 13485, Canadian regulations, Australian Regulations, Tissue Banking standards and state regulations.
Assess group and company performance through the use of metrics.
Participate in external associations, trade groups and working sessions to maintain familiarity with changing regulatory inspection trends, compliance best practices and industry standards. Insure that this knowledge is transferred to LifeCell employees through interaction, training and process improvements.
Manage the Regulatory Compliance budget and expenses.
Develop a pipeline of future leaders within Quality and advocate leadership development across the organization. Assess training needs for the Quality Control organization and insure implementation.
Perform other Quality assignments as required.
Bachelors degree in Medical, Science or Engineering field. MS or MBA degree preferred.
5-7 years experience medical devices, biologics or pharmaceuticals.
Other Required Skills:
5 years experience in a Regulatory Compliance leadership position
Familiarity with FDA and Global Medical Device and Human Tissue regulations
Track record of mentoring high performing individuals
Strong interpersonal, negotiation and communications skills
Ability to make Quality and Compliance decisions in a business environment
PREFERRED SKILLS AND EXPERIENCE
- Knowledge of human anatomy and basic understanding of disease processes and clinical events.
- Knowledge of relevant trade groups for medical devices and human tissue.
- Demonstrated experience with diverse groups including management at all levels.
- Willing to travel both domestically and internationally, as needed.
Global regulatory audits
American Association of Tissue Banks, "Standards for Tissue Banking"
Leadership in standard setting through industry groups and discussion forum events
Demonstrated knowledge of Supplier Quality standards and requirements
LifeCell Corporation - 22 months ago
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