Experience:
5+ years of experience
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Employment Type:
Part time
Posted:
4/21/2019
Job Category:
Health Care Provider
Regulatory Affairs Specialist DSM
(This job is no longer available)
DiaSorin | Cypress, CA
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Job Description

Job Title

Regulatory Affairs Specialist DSM

Job Facts

Legal Entity

DiaSorin Molecular LLC

Cypress, CA

United States

Organizational Area

USA and Canada

Country / State

United States

Place of work

Cypress, CA

Home/Office based

Office based

Professional Family:

* Quality

Reporting To

Sr. Director, Regulatory & Clinical Affairs , North America

Kind of contract

Full Time / Part Time

Full Time

Permanent / Temporary

Permanent

Job ID

USA 2018-052

Job Scope

Your Mission

The Regulatory Affairs Specialist reports to the Sr. Director, Regulatory & Clinical Affairs , North America and is based at our global Molecular business headquarters in Cypress, California.

This role will ensure compliance to FDA and other applicable regulations and regulating bodies. The Regulatory Affairs Specialist prepares, analyzes, and executes submissions to various governing agencies and, with their expertise, is a key contributor in the delivery of new and innovative products.

Main Responsibilities

Your Contributions

* Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities
* Maintain current knowledge and expertise of the regulatory landscape in order to provide expert input and guidance to the business.
* Liaise with regulatory agencies on routine matters in addition to pre-clinical, pre-submission and submission discussions

Qualifications Experience Personal Strengths Mobility

You

Education

Bachelor's Degree

Specialization

Minimum Bachelor's degree in Biology, Immunology, Microbiology, Biochemistry, Med Tech or related field is required

Experience

* Minimum 5+ years experience regulatory affairs in medical device, pharmaceutical or biotechnology or in-vitro diagnostics (IVD) industry
* U.S. and/or European/International regulations and standards knowledge is required
* Prior experience with the FDA and/or other regulatory agencies is required
* Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends

Are you ready to make an impact at DiaSorin?

We seek out employees who are inspired by our mission and who thrive in our collaborative, fast paced and entrepreneurial culture.

Technical Competencies

* Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends

Skills

* Must have the ability to understand and interpret regulatory requirements and technical standards.
* Must possess the ability to identify issues and initiative to recommend solutions.
* Must have the ability to understand and translate implications of regulatory requirements on company policies and strategies.

Languages

Fluent spoken and written English

Travel Availability

N/A

Relocation Availability

Domestic USA candidates only eligible to work in the U.S.

Training Required

N/A

Benefits

We Offer You

Why people join DiaSorin

* We are known for quality, excellence in customer care and innovative diagnostic products and instrumentation
* We have energy, passion, drive and focus on delivering results because what we do impacts patients each and every day
* We have dedicated and talented employees on our team with an excellent reputation within our industry
* We are active in the communities in which we operate
* We are guided by our strong ethical values
* We are a global company headquartered in Saluggia, Italy with a large presence in North America
* We offer a competitive total rewards package

Others Information as per Local Legal Requirements

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 https://www.uscis.gov/e-verify EEO is the law. http://bit.ly/2NLB2RJ EEO Supplement http://bit.ly/2CNcC9C (2018).

About DiaSorin

DiaSorin is the embodiment of a tradition of growth and excellence focused on the improvement of human health. With more than 40 years of international experience, the DiaSorin Group develops, produces, and distributes immunoreagent kits for clinical diagnostics. Thanks to its well established expertise, specifically in the immunodiagnostics market, DiaSorin has become "the" in vitro diagnostics specialist. Over the years, by making available to the medical profession tests that can provide optimum guidance in making clinical decisions, DiaSorin has contributed to improving the delivery of health care and reducing its cost. The Group, which consists of 12 companies based in Europe, the Americas, and Asia, operates three production facilities in Saluggia (Vercelli, Italy), Dietzenbach (Germany) and Stillwater (USA). It has over 800 employees, more than 70 of whom engage in research and development activities. Thanks to the combined reach of a direct sales force and an international network of more than 80 independent distributors, DiaSorin's sales organization is active in over 60 countries with a diversified line of technologies tailored to the needs of the different markets it serves.