Regulatory Affairs Manager - (Bethlehem, PA)

Our client, a leading medical device company, is currently seeking an accomplished Regulatory Affairs Manager to join the team. Here is an overview of the role: 1) Manage, coordinate and supervise activities of regulatory staff 2) Plan the budget and implement regulatory compliance strategies 3) Review and approve applicable product and manufacturing changes for development projects to ensure adherence to company’s quality systems qualifications 4) Oversee clinical trials or studies, including selection criteria and regulatory input 5) Prepare various compliance reports for executive management and internal quality teams to provide details on the regulatory and quality systems 6) Develop, implement and train employees on quality systems 7) Maintain current quality systems regulatory standards/guidance documents in applicable database locations 8) Carry out qualifications of the company's quality system 9) Participate in trade and professional organizations