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Regulatory Affairs Specialist

Company name
About DiaSorin Inc. (Stillwater, MN)

Stillwater, MN

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3 hit(s)  


March 13, 2018


Stillwater, Minnesota




Full Time - Experienced


Postmarket Surveillance, Quality/Risk Management, Regulatory Compliance, Submission & Registration

Required Education:

4 Year Degree


Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Assure that DiaSorin products comply with United States and international in vitro diagnostic medical device and import/export regulations. Correspond with governmental agencies and/or foreign distributors to determine product registration requirements and to provide evidence of compliance. Supports applicable regulations including Local, State, Federal and/or International requirements.


Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions

Coordinate the completion and submission of regulatory product files to result in timely and efficient registration of products (for initial registration of new products and market extension for current products)

Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.

Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies

Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends. ]

Establish and maintain procedures describing regulatory affairs activities according to the DiaSorin Quality System



BS/BA or higher in life sciences or engineering or equivalent experience


2-5 years medical device regulatory experience or equivalent

Must have knowledge of U.S, Canadian, European and other International in vitro diagnostic regulations and standards.

Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.

Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles and regulatory trends.


Highly developed written and verbal communication skills

Understanding of immunoassay principles

Working familiarity with statistical methods

Strong written, verbal communication skills and attention to details

Strong working knowledge of MS Word, Excel, PowerPoint, Gmail / Google Calendar


Fluent spoken and written English

Relocation availability:

Domestic USA candidates only

JOB POSTING REQUIREMENT for USA VACANCIES for DiaSorin Inc. and DiaSorin Molecular LLC

Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future. It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit

EEO is the law.



Additional Salary Information: WE OFFER YOU

As per local and Company requirements for DiaSorin, Inc.

Internal Number: DSU-SF723-MP

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About DiaSorin Inc. (Stillwater, MN)

DiaSorin Inc. offers the broadest, fully automated Infectious Disease and Specialty Diagnostics menu including Best-in-Class Vitamin D. These quality assays are analyzed on the versatile LIAISON® XL platform. We provide value through sales, service and support solutions to Hospital and Reference Laboratories by consolidating their menu in order to streamline processes and increase efficiency. US Jobs Recruitment Portal: (SAP SuccessFactors)

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About DiaSorin Inc. (Stillwater, MN)

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