Regulatory Affairs Manager- Remote or Rochester, NY, Raritan, NJ
Full Time
Remote
Posted
Job description
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 QuidelOrtho 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 Clinical Labs, Transfusion Medicine and Donor Screening Units. Position can be located in Rochester, NY, Raritan, NJ, or fully remote
The Responsibilities
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Reviewing and interpreting regulations/guidance documents to develop regulatory strategy to support Clinical Labs, Transfusion Medicine and Donor Screening project teams in terms of regulatory submission pathway, predicate device selection, submission requirements, timing, and risks.
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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.
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Make judgments about operational impact of proposed actions, identifies, and interacts with appropriate resources in order to successfully achieve company and regulatory strategy objectives.
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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.
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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.
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Identify and/ or lead 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. Coach, mentor junior staff.
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Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes.
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Perform other work-related duties as assigned.
The Individual
Required:
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Bachelor’s degree in a scientific or related discipline; or equivalent combination of education and experience.
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Minimum 8+ years of experience in a regulated Medical Device Industry required
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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) CE Mark under current IVDD and IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations.
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Excellent interpersonal, teamwork, and verbal/written communication skills are required. 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.
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Ability to mentor and coach junior-level staff as well as cross-train with peers.
Preferred:
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RAC (Regulatory Affairs Certification)
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In Vitro Diagnostic or Biologics Industry experience.
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Previous people management experience
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Experience submitting
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Use or Process Excellence (PEx) tools for process improvement initiatives is a plus.
The Key Working Relationships
Internal Partners:
- R&D team
- Tech Transfer team
- Technical Medical Affairs
- Design Quality team
- Product Management
- Product Marketing
External Partners
- Industry Regulatory Groups
- US Regulatory Agencies
The Work Environment
This role operates in a typical office environment and has the option to be hybrid or fully remote. Travel for this role will depend on your location with an expected 0-10% travel.
Salary Transparency
The alary 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 $117,000 and $235,000 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.
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 the 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
orthorecruiting@orthoclinicaldiagnostics.com
#LI-Remote
#LI-AP1
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