Manager, Regulatory Affairs

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

• Manage the Regulatory Strategy for product registration in the assigned region / country. Implement this strategy.
• Assist customers / distributors in addressing regulatory issues with respect to product licensing as needed.
• Communicate and direct activities pertaining to FSCA (Field Safety Corrective Actions) and FSN (Field Safety Notices).
• Develop and maintain technical documentation for compliance to applicable regulations; participate in the preparation of the respective documents.
• Interact with and support the Quality organization to ensure compliance of the quality management system with regulatory requirements, in particular quality management requirements acc. to IVDR, cGMP, MDR.
• Develop and track metrics for department performance.
• Ensure compliance with Health Authorities regulations and function as a contact for the Authorities as needed.
• Facilitate accurate and timely approval of submissions by ensuring compliance with regulations and interpretations.
• Interact with regulatory agency personnel in order to expedite approval of applications, and responses to questions.
• Lead and participate in projects as assigned by management to improve regulatory processes and facilitate best practice approach to drive functional excellence.
• Maintain library of regulatory and clinical standards and accepted practices applicable to Haemonetics' areas of business.
• Participate in audits and other regulatory agency inspections.
• Partner effectively with other Regulatory Affairs staff and cross functional departments to develop regulatory approval strategies for products.
• Partner with R&D, Marketing and other cross functional groups to compile appropriate technical information for supporting various regulatory submissions.
• Provide training and regulatory guidance, subject matter expertise to product development teams regarding regulatory requirements, SOPs, good regulatory practices and emerging regulations.
• Responsible for responding to requests from distributors, agents and / or Regulatory Agencies on new submissions or renewal of submissions.
• Provide guidance to regulatory and quality staff in the management of requirements and documentation related to local regulations.
• Review proposed design and / or labeling changes to ensure regulatory compliance.
• Work with the Quality organization to determine reportability for product complaints.
• Participate in clinical trial design and monitoring.