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.

As we continue to grow as QuidelOrtho, we are looking for an Associate Director, Regulatory Affairs who will implement and manage regulatory activities with direct responsibility for dissemination of new and changed regulatory requirements. This person will also provide guidance to product development teams on regulatory issues for the planning and compilation of critical documentation relating to the development process for the suitability for submission. The Associate Director will ensure Quality Systems compliance with QSP, ISO, CMDR, IVDD and other worldwide regulatory requirements as appropriate, and promotes awareness of applicable regulatory and customer requirements by ensuring that applicable requirements comprise an integral part of the new hire orientation process, as well as during the regular operations and management review meetings.

The position can be located in Athens, OH, San Diego, CA, or Remote.

• Prepares /oversees the preparation of various regulatory submissions including Pre-Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications.

• Monitors new and changing regulations and guidance and disseminates information to stakeholders.

• Identifies regulatory trends and conducts key regulatory intelligence updates on a global basis.

• Represents QCI on US trade associations and contributes to trade positions.

• Provides regulatory support for diagnostic product development and commercial diagnostic products.

• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally.

• Secures all material required for submissions, license renewals, and annual registrations.

• Works with governmental regulatory agencies and other third-party accrediting bodies.

• Maintains approvals/licenses/authorizations for existing marketing authorizations.

• Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.

• Reviews validation reports for regulatory submission soundness.

• Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.

• Reviews advertising and promotion to ensure compliance with product claims.

• Maintains expertise with appropriate US and international governing statutes and regulations and initiatives for impact to the Company.

• Contributes to management review for new or revised regulations and/or other quality system activities.

• Bachelor's Degree or equivalent combination of certification and proven work experience.

• 10+ years of progressive responsibility and experience in Quality Systems in Medical Device Manufacturing Environments, US and international.

• Extensive experience in managing and developing people, projects and systems.

• Must have demonstrated experience in preparation and submission of regulatory documentation including, but not limited to, 510(k), PMA, CLIA reclassifications, international registrations and technical files.

• Managerial Skills - Employee Development / Career Development / Financial Accounting.

• Communication Skills - Excellent Written and Oral Skills. Good listening skills.

• Excellent leadership and team building skills complemented by 'hands on" style or capabilities.

• This individual must possess a complete knowledge of Quality System requirements (ISO, CMDR, QSR, IVDD and other worldwide regulations as appropriate) a sense of the current and future regulatory climate and a pragmatic approach in developing, implementing and administrating the quality system within defined regulations while meeting corporate strategic objectives.

• This individual must be able to effectively manage multiple priorities in a fast paced and dynamic environment. This position requires the effective communication, persuasion and technical skills todevelop,present and implement ideas to senior corporate management.

• The individual must be knowledgeable with respect to quality systems, regulatory standards, product development and project management.

• The Associate Director, Regulatory Affairsmust determine the appropriate strategy and evolution of the corporate regulatory system. This individual is responsible for defining and directing decisions to support the quality policy. The Associate Director is responsible for prioritizing initiatives and focusing resources to optimize the impact on the company's strategic imperatives.

• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.

• Proficiency in the English language, both written and verbal.

• Regulatory Agencies/Customers - The incumbent is the liaison and the company representative between Quidel Cardiovascular Inc. (QCI) and external regulatory parties on matters relating to QCI's regulatory product submissions associated with FDA, ISO, CMDR, IVDD and other regulatory bodies as applicable.Provides guidance on to QSR, ISO, IVDD, CMDR regulations. Directly interacts with regulatory agencies (FDA, ISO Registrar, etc.) and product customers and corporate partners on technical, regulatory issues.

• Persuades and directs peers and management on the attitudes and practices of regulatory compliance throughout the organization.

• Works closely as a project team member with various project development teams, providing guidance in support of product filings/registrations requirements.Interacts with clinical coordinators on study design, protocol development and data analysisin order toachieve intended use claims.

• The work environment characteristics are representative of an office environment.

• No strenuous physical activity, though occasional light lifting of files and related materials is required.60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional travel required.Travel includes airplane, automobile travel and overnight hotel.

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, 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. An salary range for this position is $110,700 to $203,000. 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

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