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Regulatory Affairs Manager

CEDENT

Santa Clarita, CA

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Calendar Management, Coaching, Communication Skills, Computer Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Detail Oriented, Distribution Warehousing, Durable Medical Equipment, External Audit, Facilities Management, Federal Laws and Regulations, Internal Audit, Leadership, Legal Documents, Licensing, Maintain Compliance, Marketing, Medical Equipment, Medical Terminology, Microsoft Product Family, Multitasking, Negotiation Skills, Operations Management, Organizational Skills, People Management, Performance Metrics, Performance Reviews, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Safety Standards, Safety/Work Safety, Sales, Schedule Development, State Laws and Regulations, Strategic Planning, Target Marketing, Time Management, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Santa Clarita, CA
POSTED
30+ days ago
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.

About the Company

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CEDENT

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