The Regulatory Affairs Manager will provide leadership and direction in the implementation of regulatory policies, procedures, and strategies that assure domestic and global regulatory compliance. The Regulatory Affairs Manager will be responsible for RA operations of key businesses with global footprints, to ensure that business objectives are achieved and comply with applicable regional/country regulations. The Regulatory Affairs Manager will manage an RA staff focused on the development and commercialization of new device products and support of current products.  The Regulatory Affairs Manager will act as the RA representative for specific facilities and will represent the company in interactions with regulatory agencies, customers and purchasing organizations, outside companies, and relevant professional organizations.

The Regulatory Affairs Manager will lead RA teams, responsible for providing new regulatory registrations/submissions and registration maintenance to assure business units achieve their objectives while ensuring compliance with applicable regulatory requirements.

Our medical device clients seek regulatory affairs leaders who are career-driven, have strong management and analytical skills and a depth of experience in managing regulatory affairs teams.  Our companies offer excellent career growth potential and benefits. We have many opportunities – all with top medical device companies seeking the best in regulatory affairs leadership.

typical roles and responsibilities for Regulatory Affairs Manager

  • Provide strategic leadership to their respective business teams, effective communications/negotiations with regulatory bodies, and must establish a capable and responsive regulatory affairs team to ensure that objectives are achieved.
  • Leadership in Regulatory Affairs and ComplianceRegulatory representative during FDA, Notified Body, and external agency inspections
  • Impactful communications with regulatory agencies, problem solving and resolution as well as complaint and product failure investigations
  • Monitor and trend staff performance

Requirements for the Regulatory Affairs Manager

  • Four-year technical degree
  • 7+ years’ of relevant regulatory experience
  • In-depth knowledge of applicable regulatory law, knowledge of quality and business processes
  • Excellent analytical and statistical skills
  • Experience interfacing effectively with domestic and international regulatory agencies
  • Experience should include in-depth knowledge of domestic (FDA) and international regulatory requirements and medical device registrations, design control activities for medical devices, as well as direct management of FDA and Notified Body inspections
  • Strong communications (written and oral), analytical, quantitative and problem solving skills are required