Regulatory Affairs Mdr Project

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
- Cross-functionally work with a project team that includes RA, R&D, Marketing, Legal, Business Unit leaders and third party companies to execute projects in accordance with the MDR timeline deliverables.
- Review and approve documentation and SOPs to support Technical Documentation to meet MDR requirements.
- Participate in cross functional teams to discuss and revise documents to meet MDR requirements.
- Collaborate with stakeholders to develop and maintain project plans.
- Monitor and analyze project risks. Communicating any identified critical path or roadblocks along with mitigation strategies to the project team.
- Ensure project plans and deliverables are compliant with applicable procedures and/or regulations.
- Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
- Support submission review process with Notified Body.
- Communicate the potential implications of product changes to the broader International Regulatory Affairs team to be incorporated into International Registration timelines.
- EEO Policy Statement