Job description
The Career Potential
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 Opportunity
As we continue to grow, we are seeking a Senior Regulatory Affairs Associate whose primary responsibility is to support the day-to-day regulatory affairs base business operations within both Clinical Laboratories and Transfusion Medicine Regulatory Affairs. The Senior RA Associate, with minimal oversight, will also manage and oversee the coordination, compilation and submission of regulatory applications to health authorities. This position can be located in either Pencoed, Wales, UK; Raritan, NJ; Rochester, NY; or Pompano Beach, FL and can be remote.
The Responsibilities:
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Provide regulatory support to Clin Labs and Transfusion Medicine project teams in terms of submission requirements, timing, and risks. Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters. Prepare submissions to meet regulatory agency expectations
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Support base business activities, such as Annual reports / 30 DN / CBE-30 / PAS, Labeling reviews, GUDID, and change management reviews for regulatory submission impact. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives
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Identify and/ or support process improvement projects to streamline current activities and increase department efficiencies.
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Development goals, such as webinars, review FDA website and articles, read journals, attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs.
The Individual
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Bachelor’s degree in a Scientific or related field is required.
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Minimum 6-8 years of experience in an FDA regulated Medical Device or Pharmaceuticals Industry required, IVD and/or biologics Industry experience preferred.
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A minimum of 3 years of experience developing and executing Regulatory strategies and Product Development for complex 510(k) and/or BLA development programs is required, In Vitro Diagnostic experience is preferred.
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Excellent interpersonal, teamwork and verbal/written communication skills are required.
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Good organizational skills and an ability to manage multiple tasks/projects/priorities
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The ability to demonstrate model behavior, understands priorities and encourages others to drive for results will be needed.
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Ability to mentor junior level staff as well as cross-train with peers
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The ability to work with business partners across geographies and time zones is critical.
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, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $80,000 and $143,000. 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.
EOE/AA Disability/Veteran
#LI-Remote
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