Regulatory Affairs Specialist 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 coordinator provides administrative support to the regulatory affairs team and leadership group. The coordinator facilitates the processing of regulatory documents and serves as the lead for requesting legalized documents necessary for medical device registration activities. Manages the internal processes for requesting purchase orders, FDA site establishment registrations, site licenses and annual reports. Maintains the RA calendars and prepares the department metrics.

• Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms.

• Manage requests for regulatory document apostilles and legalization services.

• Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, leave, vacations, and team activities.

• Interact with the department team member to generate monthly metrics and reports to ensure consistency and accurate reporting.

• Interact with global regulatory leaders and peers to share and manage department metrics and KPIs.

• Interact with regulatory affairs team member to formulate/review standard operating procedures, work instructions and other regulatory processes.

• Provide administrative support to the regulatory submissions processes, as needed, such as formatting and/or publishing.

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

• Manage the FDA registration databases for device listings updates, initial entries and changes.

• Assist with on-boarding of new RA associates.

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

• Provide notary services for the regulatory affairs group.

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

• 1-2 years of prior experience in regulatory affairs.

• 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.

• 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 position that can be worked from anywhere in the US.

• Travel - 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 $65,000 to $75,000 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 their 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.

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