Regulatory Affairs Manager

Regulatory & Quality Affairs Manager

Client 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:

• 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.