Principal Regulatory Affairs Specialist - Cypress, CA, United States - USA 2021-067

Job Title

Principal Regulatory Affairs Specialist

Job Facts

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

Professional Family: 

  • Quality
Reporting To
Director

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2021-067

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.

DiaSorin Molecular, LLC is headquartered in Cypress, Ca. Our technology enables diagnosis of disease by detecting specific RNA and DNA sequences. We focus on design, development and cGMP Manufacturing.

Main Responsibilities

Your Contributions

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

We are looking for an advanced Regulatory Specialist that will provide pre-market regulatory strategy planning and implementation to ensure regulatory requirements are incorporated and approved for new and modified products. Utilize your expertise in European regulations, in-vitro diagnostics and trade compliance.
What will you do?

-Prepare regulatory assessments of product changes, documenting rationale, actions and following through with notifications internationally as needed.
-Create/ revise/ review and submit Annual Reports for US and Canada.
-Provide international STED submissions and requested declarations and other documentation to subsidiaries/distributors to obtain and maintain registrations.
-Participate in regulatory training and transfer the information back to the Regulatory department providing insightful application.
-Communicate regulatory information to assist with trade compliance, CDC, and import/export activities.
- Author 510(k)  perform reviews for submissions at other DiaSorin sit

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Regulatory Affairs
Experience

What will you bring to the table?

-Bachelor’s Degree in life science or engineering.
-5 years minimum Regulatory medical device experience, at least several years in IVD, doing US, European, and or international submissions.
-Prior experience in interacting with FDA staff and/or other regulatory agencies and demonstrated success in securing regulatory approvals.
-Knowledge of US, European, international regulations and standards, and experience in preparing regulatory submissions
-Proven analytical capabilities, solid understanding of manufacturing and change control, and good manufacturing practices.
-Ability to speak effectively before groups of customers or employees of organization and ability to organize information to compose reports, documents and presentations.
-Knowledge/Understanding of USDA, CDC, import/export requirements for imported animal/human raw materials and finished goods
- Experience authoring procedures and determining applicable regulations/standards/guidance for products/processes.
- Experience in authoring of IVD 510(k), EU IVDR, and Canada licenses preferred.

Technical Competencies

Regulatory Submissions
510k
MDR
IVDR

Skills

510k
MDR
IVDR

Languages
English
Travel Availability
As Needed
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.