Regulatory Affairs Manager (Santa Clarita, CA)
- Interact with business leads at all relevant facilities to partner to maintain compliance standards and foster market expansion and growth.
- Ensure that known compliance risks (via internal/external audits, changes in regulations, changes in business structure/products) are mitigated via quality/compliance plans.
- Effectively track and communicate compliance plans with HS/Business Leadership.
- Ensures the QA/RA organizations fully understand the requirements of all regulatory requirements for the company.
- Direct and oversee Quality Assurance internal audit schedules (internal and supplier) and programs to ensure effective and timely audits. Facilitate and promote cross audits across businesses.
- Monitor all corrective and preventive action (CAPA) programs to ensure actions are identified and completed in a timely and risk-based manner.
- Manage external inspections from Regulatory including developing responses to any inspection findings.
- Oversee facility practices and conditions related to the safe handling and storage of medical devices, pharmaceutical and food products to ensure the appropriate health and safety standards are being maintained.
- Plan and execute state licensing applications (DME supplier, distributor, pharmacy), and support the continuous renewal and overall maintenance of the company’s operating licenses.
- Select, develop, and evaluate staff to ensure the efficient operation of the organization. Provide coaching and guidance to direct reports through regular meetings, on-site visits, and communication.
- Ensure staff performance review metrics are provided and maintained, and training is provided to meet job qualifications and regulatory compliance.
- Participate and communicate on regulatory and compliance issues during regularly scheduled management review meetings and ad hoc as required.
- Participates in special projects and performs other duties as assigned.
- Knowledge of quality and regulatory requirements, state/federal regulatory requirements concerning the distribution and dispensing of medical device, pharmaceutical and nutritional food products.
- Strategic planning to ensure Quality and Regulatory systems and processes remain current and compliant.
- Ability to lead and manage complex projects.
- Excellent decision-making skills.
- Excellent analysis and problem-solving skills.
- Excellent organizational skills and extreme attention to detail.
- Demonstrated success in negotiations with regulatory bodies and/or notified bodies and other participants.
- Excellent written and verbal communication skills (including interaction with both internal personnel and external organizations such as regulatory agencies and customers).
- Ability to read, analyze, and interpret technical journals, legal documents, test reports, clinical and medical terminology, technical product information, and complex documents.
- Strong PC computer skills with everyday experience working with Microsoft products.
- Multi-tasking is essential for this position. A high energy level and comfortability performing projects in conjunction with day-to-day activities.
- Ability to speak effectively before groups of employees, management, and agency representatives.
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