Director of Global Regulatory Affairs

Primary location - Deland, Florida, United StatesPossible other work locations -New Port Richey, Florida, United StatesTimonium, Maryland, United StatesPort Washington, New York, United StatesPutnam, Connecticut United StatesCortland, New York, United States5+ direct reports  Director Global Quality and Regulatory Compliance   JOB SUMMARY   Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
Investigates and resolves compliance problems, questions and complaints.
Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.
Executes appropriately on product recalls.
Respond to regulatory agency inquiries.
Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
  POSITION OBJECTIVES   Responsible for the effective implementation of the organization’s compliance reporting activities for all Business units within Industrial including Aerospace, Energy+, Microelectronics and Food and Beverage applications.Responsible for ensuring product meets all product claims specifications and regulatory requirements throughout the product lifecycle.Establishes and maintains an effective Industrial QMS that provides compliance to relevant international standards, customer requirements and regulatory requirements.Maintains oversight of regulatory requirements to ensure changes are adopted with minimum disruption to implemented, controlled, and sustained throughout the business and meet PO requirements.Proactively Engage with R&D/Design engineering and Product planning teams to ensure new product/material design complies with regulatory requirements for intended markets.  EDUCATION/PRIOR EXPERIENCE REQUIREMENTS    BS/BA REQUIRED with a preferred relevant engineering major, Quality related field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards.
GMP, FDA knowledge and other ISO standards an advantage.Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)  The salary range for this role is 155,000 - 180,000 + 20% Meet Your Recruiter Sean GouldingVice President – Technical Recruiting, Skilled Labor, Accounting And Finance Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing.
With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs.
In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products.
In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.
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