What are the responsibilities and job description for the Regulatory and Quality Affairs Manager position at Shield California Health?
Since 1957, Shield Healthcare has provided high-quality healthcare services while focusing on customer satisfaction and employee achievement. We are dedicated to fulfilling the medical supply needs of consumers and the caregiving community while maintaining a 99% overall customer satisfaction rating. Over the years, Shield HealthCare has expanded nationally with current service locations in California, Colorado, Illinois, Ohio, Texas and Washington.
Shield HealthCare is looking for a Regulatory & Quality Affairs Manager for our Valencia, CA corporate office. The Regulatory & Quality Affairs Manager ensures all facilities and or business entities maintain full compliance with all applicable state & federal regulatory requirements and guidelines for the marketing, sales, warehousing and distribution of the company's products in their respective target markets.
JOB RESPONSIBILITIES :
- 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.
QUALIFICATIONS :
SALARY & BENEFITS :
Career-minded individuals will find our business challenging and our reputation for excellence just one of the rewards we have to offer. To further enhance this tradition of excellence, our employees participate in continuous training and development programs in a variety of disciplines.
Salary : $110,000 - $140,000
