Regulatory Affairs Specialist I - Stillwater, United States - USA 2022-180

Job Title

Regulatory Affairs Specialist I

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Stillwater
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2022-180

Job Scope

Your Mission

For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.

Main Responsibilities

Your Contributions

Developing Regulatory Specialist with a background in science, skilled communicator, and quick learner. Specialist works as an important part of the team to learn regulatory requirements of all countries and to submit applications for registrations. Demonstrated progression will lead to more types of submissions, regulatory activities, and responsibilities. May hold position as lead for an activity such as labeling, international submissions, etc.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Life Science or Engineering
Experience

Bachelors Degree in life science or engineering or 2-5 years experience in the field.
Detail-oriented, level-headed team player that can work well with others to accomplish goals.
Demonstrated skills in communications, both written and verbal, including detail to spelling and grammar.
Ability to navigate new systems and become readily proficient
Acts responsibly to lead the company toward regulatory compliance and voice concerns.
Willingness to learn and grow as an individual, as part of a department and a company
Experience in IVD device company preferred.

Technical Competencies

Follow procedures to maintain compliance with regulations, standards and guidance's.
Assist cross-functional teams with regulatory information such as licenses, listings, and classifications.
Create, revise, review, and maintain regulatory compliance for labels and IFUs.
Use a variety of systems to complete tasks and maintain records.
Provide international STED submissions and requested declarations and other documentation to subsidiaries/distributors to obtain and maintain registrations.
Update European/international technical files as needed when there are changes to products, testing, manufacturing, claims, file requirements or labeling.
Be accountable in maintaining quality work and supporting a work environment of continuous improvement to increase efficiency, quality and compliance.
Participate in training and education seminars to grow regulatory knowledge.
Submit Canadian license applications and amendments.

Skills

Assist with other duties as opportunities arise.

Languages
English
Travel Availability
NA
Relocation Availability
NA
Training Required

YES

Benefits

We Offer You

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Others Information as per Local Legal Requirements

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal Employment Opportunity

Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482.