Regulatory Affairs 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 the Regulatory Affairs Specialist performs regulatory activities related to the life cycle management of IVDs (in vitro diagnostics and medical devices) including registrations in the worldwide market, as directed

This position is eligible for remote.

The Position

• Prepares regulatory documentation for domestic (FDA) and international (e.g., EU, etc.) product submissions and registrations.
• Assists in the creation and maintenance of technical files in accordance with applicable standards and regulations.
• Evaluates change control documents for impact on submissions and filing requirements.
• Reviews and approves product labeling and marketing collateral.
• Research regulations and competitor products and create summaries for departmental use.
• Participates on project teams, as qualified, and responsible for providing guidance on regulatory issues and procedural recommendations for standard operating procedures and protocols.
• Participates in internal auditing and training systems to ensure compliance with quality system.
• Provides support during facilities inspections, licensures and permits, as needed.
• Maintains trackers and reports on status of regulatory activities to RA management.
• Performs other regulatory activities based on level of experience.
• Carries out duties in compliance with established business policies.
• Perform other work-related duties as assigned.
  
  

The Individual

Required

• Bachelor’s degree (BS/BA) in a scientific discipline is required; BS/BA in a biological science is preferred.
• Minimum of 3 years’ prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment is required.
• Minimum of 2 years’ prior experience in Regulatory Affairs (or related work experience) is required; an advanced degree may be used to substitute for work experience.
• Strong knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment is required.
• Ability to work cohesively with multi-disciplinary scientific working groups is required.
• Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups is required.
• Must possess a high degree of accuracy and attention to detail.
• Ability to work independently and be self-motivated is required.
• Ability to work under moderate supervision following established procedures is required.
• Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner is required.
• Ability to exercise judgment within defined procedures and practices to determine appropriate action is required.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint is required.
  
  

Preferred

• Proficiency with pdf publishing is preferred.
• Proficiency with electronic database management is preferred.
• Working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of medical devices (current FDA, QSR, ISO, CMDR, IVDD and other worldwide regulatory regulations as appropriate) is preferred.
• Prior knowledge of domestic and international product submissions is preferred.
  
  

The Key Stakeholders

Internal Partners

• Regulatory Affairs staff, regional quality and regulatory compliance, cross functional teams.
  
  

External Partners

• Contractors and Vendors.
  
  

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

The work environment characteristics are representative of an office environment. No strenuous physical activity, although occasional light lifting of files and related materials is required. Occasional travel required. Travel may include airplane, automobile travel and overnight hotel.

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-$75,000. 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 recruiting@quidelortho.com.