Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
TT
Hybrid Director, Regulatory Affairs – Compliance Systems and Labeling
Posted 3 weeks ago
About the role
- Director of Regulatory Affairs directing compliance systems and labeling at Terumo Blood and Cell Technologies. Leading regulatory activities and collaborating to define compliance strategy.
Responsibilities
- Provides strategic direction and operational leadership for regulatory affairs in a business area or region
- Provides strategic direction and operational leadership for global labeling
- Develops and communicates effective regulatory strategies, to meet established business goals
- Provides intentional influence to ensure a robust, day-to-day ‘culture of quality and compliance’ exists in the business area or region
- Acts as an internal champion for quality and regulatory initiatives aimed at improving business systems and compliance
- Works closely with other senior level colleagues within and outside of the company to resolve highly complex and sensitive issues
- Fosters an ongoing proactive relationship with internal R&D, Clinical, Scientific, Quality, Legal, Manufacturing and Marketing colleagues
- Influences internal customers as necessary to ensure successful strategy implementation
- Directs the professional growth of professional staff by providing individualized guidance, training and supervision
- Participates in Management Teams for business areas
- Develops Regulatory presentation for Regulatory section of Management Review and participates in the meeting
- Oversees the development of 510(k)s, IDEs, PMAs, CE Technical Files, CE Design Dossiers, NDA’s and ANDA’s and other international regulatory submissions
- Acts as primary interface with applicable regulatory bodies, presenting strategies and technology communications effectively
- Acts as Regulatory PRRC and performs required PRRC activities
- Ensures that all regulatory activities are conducted with the highest integrity in an ethical, legal and compliant manner
- Provides support for development of new products, from design inputs including clinical and regulatory specifications through comprehensive design validation support
- Determines the adequacy of new products/processes prior to and following commercial distribution
- Works closely with Quality Assurance to ensure that the Quality Management System is maintained for effectiveness in accordance with applicable standards and regulations
- Identifies areas of regulatory or compliance risk and develops mitigating strategies
- Directs compliance programs such as the Standard Assessment program, UDI compliance, and State License program as well as Regulatory Operations
- Identifies areas of regulatory, or compliance risk and develops mitigating strategies and works to implement solutions cross-functionally
- Monitor and drive solutions for changes in regulatory environment that have the potential to impact Terumo BCT business and participate in industry groups for pro-active engagement
Requirements
- Four-year college degree required
- advanced degree in the physical sciences considered a plus
- Professional education in Regulatory Sciences desired with regulatory certification a plus
- Minimum of 10 years regulatory experience with increasing responsibility in the medical device or pharmaceutical industry
- Experience with both sterile disposables and electro-mechanical medical devices with embedded software preferred
- Experience with pharmaceutical submissions (NDA/ANDA in eCTD format) or medical device submissions (510(k), PMA, CE mark, etc.)
- Minimum 5 years managerial experience with multiple direct reports
- Demonstrated track record of representing unique technologies to regulatory authorities and gaining timely approvals is critical
- Work with drug/device combination products is desired
- Experience working closely with clinical experts in all stages of clinical trials
- Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional Material review, etc.)
- Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources
- Experience working in Quality or leading a Quality team is preferred.
Benefits
- multiple group medical, dental and vision plans
- a robust wellness program
- life insurance and disability coverages
- a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
- 401(k) plan with a matching contribution
- vacation and sick time programs
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