Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Manager, Medical Safety will oversee Medical and Clinical risk assessment of customer complaints under the guidance of the Medical Safety Officer/Physician. The Medical Safety Manager will collect and generate medical and clinical evidence to support the clinical utility and safety of Ortho's key products. The Medical Safety Manager will also help to develop and review Product Quality related documents, such as Risk Management Plan, and will assist the Medical Safety Officer/Physician to assess patient safety & impact of any product quality issues.

The Medical Safety Manager will proactively assess product medical risks and mitigate potential harm/hazards during product development. He/She will work with the Quality and Complaint Handling teams to evaluate patient risk and the impact of product quality or performance issues. The Medical Safety Manager will help guide the development of post-market safety surveillance planning and will acquire sufficient knowledge of associated medical guidelines and standard practices of Ortho's key products. This will include interaction with external medical experts on conducting and overseeing literature surveys to monitor product performance and safety. This position can be located in Raritan, NJ, Rochester, NY, San Diego, CA, or Athens, OH. Remote work options will also be considered.

• Supports the development or update of product Risk Management Plan to proactively assess product risks and mitigate potential harm/hazards

• Conducts and oversees literature search to monitor product performance and safety

• Helps the development of post-market safety surveillance reports

• Assist the Medical Safety Officer to assess the patient impact and developing health hazard evaluation on product quality issues

• Collect medical and clinical evidence to support the clinical utility and safety of Ortho's key products.

• Participates in IVDR processes or activities for post-market surveillance and supports the generation of required reports to maintain IVDR compliance of Ortho products.

• Bachelor's or master's degree in healthcare training, required. Doctor of Medicine or equivalent required.

• Hospital experience in Internal Medicine & Cardiology or ICU with direct Patient care experience is a strong plus.

• Minimum 5 years of experience working in the medical device industry in R&D, medical affairs, or quality is required.

• Previous clinical research experience is a plus

• Previous experience in developing publications is a plus

• Previous experience in vitro diagnostics industry in a Medical/Scientific/Clinical setting is a plus

• Previous experience working in a hospital clinical laboratory is a plus

• Excellent oral and written communication skills, writing skills as evidenced by publications and journal articles desired

• Excellent Interpersonal skills and ability to work effectively in cross-functional teams.

• Demonstrates quality-oriented mindset and consistent attention to detail.

• Strong analytical skills preferred, and previous research experience desired

Colorado State Posting Details: This position's starting salary is between $88,000 and $176,000 per year, and it is bonus eligible. Salary will be determined by the education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time) and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

EOE/AA Disability/Veteran

#LI-Remote