Job Description
Job Description: TransMedics' pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage, by preserving donor organs in a living, functional state during transport. Unlike traditional cold-storage methods, the OCS Systems feature warm, normothermic perfusion, and provide the means to monitor organ health so that transplant patients can experience better outcomes. We are laser focused on transforming the standard of care - increasing organ utilization and transplant volumes, improving patient outcomes, and reducing transplant costs, resulting in more transplantable organs being made available so that more patients can benefit from life-saving transplant procedures
Due to rapid growth, we are currently looking for a
Senior Specialist, Regulatory Affairs , based in our Andover, MA headquarters, to join us as we revolutionize this cutting-edge medical field. If you are looking for a forward-thinking and fast-paced entrepreneurial culture, you thrive on challenges and are interested in furthering your career, we want to talk to you!
ESSENTIAL TASK AND DUTIES INCLUDE: - Prepare and maintain regulatory submissions and registrations of complex Class III devices in the US and in international markets
- Maintain documentation and perform project management tasks to support compliance with applicable regulatory requirements in the US and worldwide.
- Assist with the preparation of international regulatory documents, including EU Technical Files and documentation related to EU MDR certification
- Assist with vigilance reporting in the US and around the world
- Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations
- Participate and provide support for FDA, Notified Body and internal audits as required
- Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules.
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
- Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements as needed
BACKGROUND AND QUALIFICATIONS: - 5+ years regulatory experience in the medical device industry with a proven record of successful regulatory submissions (Class III experience preferred but not required)
- Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
- Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
- Ability to utilize effective analytical and decision making skills
- Ability to act independently to determine methods and procedures
- Must be detail oriented with strong organizational skills
- Must have strong interpersonal skills with willingness to be held accountable for deliverables
- Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities
EDUCATION: - Bachelor's in Engineering, Life or Biological Sciences, or related field, Master's Degree a plus
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
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