Regulatory Affairs Manager jobs in Somerset, NJ

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 Regulatory Affairs Operations and Intelligence Senior Manager implements and facilitates processes to ensure efficient operation of the regulatory affairs department, and related functions. Manages the regulatory intelligence process by ensuring that new or changing global regulatory requirements are organized, accessible, and assessed for business impact. Leads a group of RA staff who support the regulatory operations and regulatory intelligence process.

This is a remote position.

• Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions

• Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics and KPIs.

• Interact with departments to generate standard operating procedures, work instructions, protocols andreport templates to ensure consistency and expedite submission process.

• Provide routine support to regulatory submissions processes, as needed, such as formatting and publishing.

• Implement and maintain a regulatory intelligence database for access by the Regulatory Affairs department.

• Monitor government, industry, and standards publishing agencies' websites, news feeds, and distribution lists to track new and changing regulatory requirements.

• Represent QuidelOrtho in Medical Device associations and communicate to the team on upcoming guidances, standards and regulations.

• Collect inputs from the team to provide comments to draft guidances and regulations.

• Review and generate a gap assessment report on new guidances and standards to provide to management and recommend follow up measures.

• Lead a team of direct reports, with overall responsibility to ensure proper staffing, coaching, development and performance appraisal.

• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

• Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group.

• Recognize potential problems, including situations thatinclude ambiguity, by actively reviewing and analyzing internal and external factors.

• Provide regulatory training to cross-functional groups.

• Perform other work-related duties as assigned.

• Bachelor's degree (BS/BA) in a scientific discipline is required; BS/BA in a biological science is preferred.

• A minimum of 8years of experience in Regulatory Affairs and/or related departments within the IVD or Medical Device industry or 6 years with a relevant Master's degree.

• Must have prior experience in the preparation of regulatory documentation including, but not limited to, 510(k), PMA and BLA submissions, technical files, and international registrations.

• Must have prior experience in developing processes for regulatory affairs.

• Prior direct management and/or mentorship of staff is preferred; at least 5 years of leadership experience is preferred.

• Demonstrated people development and leadership experience

• Ability, knowledge, and expertise to manage strategic regulatory programs

• Demonstrated proficiency at conveying complex regulatory information to the business in a clear, focused and concise manner.

• Advanced knowledge of quality systems and good manufacturing practices (GMP) in a manufacturing environment is required.

• Must be detail oriented with well-developed organizational and analytical skills

• Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment

• Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes

• Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets ofassociated regulations

• Able to confidently deal with ambiguous issues andprovide input towards suitable actions

• Strong oral and written communication and presentation skills

• Effective communicator of technical & non-technicalinformation

• Ability to work in a self-directed manner to see issuesthrough to completion

• IVD product experience is highly preferred

• Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat

• This is a remote opportunity that can be worked from anywhere in the US

• Travel - 5% to 10%

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 $99,000 to $198,000 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.

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

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