Regulatory Affairs Specialist DSM - Cypress, CA, United States - USA 2018-052

Job Title

Regulatory Affairs Specialist DSM

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
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).