Senior Post-Market Surveillance and Risk Management (PMRM) Specialist

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Senior Post-Market Surveillance and Risk Management (PMRM) Specialist. The Senior PMRM Specialist will work towards proficiency in becoming a subject matter expert in post-market surveillance and risk management. They are accountable for the success of compiling, writing, analyzing and submitting necessary post-market surveillance (PMS) data and reports such as Periodic Safety Update Reports (PSURs), Post-market Performance Follow-ups (PMPFs), Canadian Summary Reports, etc. and will have critical organizational and technical knowledge. They will provide guidance to the business. This position can be located in Rochester, NY or Raritan, NJ.

The Responsibilities

• Provide surveillance guidance to business partners on post market product safety and quality issues (such as for QSMRs, etc.).
• Research, collects data, and responds to requests for surveillance and risk management data evaluations.
• Compiles, writes, analyzes and submits necessary post-market surveillance (PMS) data and reports such as Periodic Safety Update Reports (PSURs), Post-market Performance Follow-ups (PMPFs), Canadian Summary Reports, etc.
• Facilitate escalation of safety and quality issues based on surveillance data.
• Act as SME in internal and external audits.
• Train to proficiency in order to establish a high performance and continuous process improvement culture, driven by metrics, benchmarking and best practice.
• Possible assistance with escalation (SQIR/PQR) and recall activities.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in Science or Engineering.
• 4 years of experience in Quality and/or Regulatory.
• Experience in a quality or regulatory role; or equivalent combination of education and experience.
• 5% travel required.

Preferred:

• Experience in medical device / IVD or clinical/blood-banking experience.

The Key Working Relationships

Internal: CHU, QRC, QRA, OrthoCare, R&D, Operations (Logistics/Supply Chain/Product Support), Commercial/Marketing.

External: Regulatory Authorities, Notified Bodies/Competent Authorities.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $65,000 - 118,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected]

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