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.
As Ortho continues to grow, we are seeking a Regulatory Affairs Manager to join our team. In your new role, your primary responsibility will be to support a team of employees of varying levels, being responsible for developing and implementing local strategies and leading of the day-to-day regulatory affairs base business operations and new product development projects within the Clin Labs, Transfusion Medicine and Donor Screening Units. Position can be located in Rochester, NY, or Raritan, NJ. Remote work options will be considered.
Reviewing and interpreting regulations/guidance documents to develop regulatory strategy to support Clin Labs, Transfusion Medicine and Donor Screening project teams in terms of regulatory submission pathway, predicate device selection, submission requirements, timing, and risks.
Interact with US FDA and/or International regulatory personnel (Corporate IRA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the 1 over 1 final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed.
Make judgments about operational impact of proposed actions, identifies, and interacts with appropriate resources in order to successfully achieve company and regulatory strategy objectives.
Reviews/ interpret product specific regulatory issues that may have material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment.
Represent Ortho to US regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions.
Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies.
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. Coach, mentor junior staff.
Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes.
Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience.
RAC (Regulatory Affairs Certification) is a plus.
Minimum 8+ years of experience in a regulated Medical Device Industry required; In Vitro Diagnostic or Biologics Industry experience preferred.
Minimum 6+ years of experience developing and executing regulatory strategies for complex projects under product development requiring a US FDA submission (510(k), PMA and BLA preferred), CE Mark under current IVDD and IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations.
Previous people management experience is desired but not essential.
Use or Process Excellence (PEx) tools for process improvement initiatives is a plus.
Excellent interpersonal, teamwork, and verbal/written communication skills are required. Good organizational skills and an ability to manage multiple tasks/projects/priorities.
The ability to demonstrate model behavior, understands priorities, and encourages others to drive for results will be needed.
Ability to mentor and coach junior-level staff as well as cross-train with peers
Colorado State Posting Details: This position's starting salary is between $117,000 and $235,000 per year, and it is bonus eligible. Salary will be determined by 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.