21 days old

Regulatory Technical Specialist 3

Berkeley, CA
**Regulatory Technical Specialist 3**

Locations:Berkeley, California

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Strategic Procurement

**Requisition Number:** 222612

**Primary Location:** United States-California-Berkeley

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 10%

**Division Description:**


is a global technology powerhouse that has stood for engineering excellence,

innovation, quality, reliability and internationality for more than 165 years.

As a global technology company, Siemens is rigorously leveraging the advantages

that this setup provides. To tap business opportunities in both new and

established markets, the Company is organized in nine Divisions: Power and Gas,

Wind Power and Renewables, Energy Management, Building Technologies, Mobility,

Digital Factory, Process Industries and Drives, Healthineers and Financial


With 45,000 employees Siemens Healthineers is one of the worlds largest

suppliers of technology to the healthcare industry and a leader in medical

imaging, laboratory diagnostics and healthcare IT. All supported by a

comprehensive portfolio of clinical consulting, training, and services

available across the globe and tailored to customers needs. So that more

people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthcare

**Job Description:**

**Position Overview**

The open position is within the

Regulatory Affairs group which is part of the Quality Management team for

Molecular products located in Berkeley, CA. The successful candidate

would be responsible for representing regulatory affairs on project core teams,

creating, coordinating and submitting 510(k)s, original PMAs, PMA addendums,

supplements, EU technical files, technical file updates and renewals for

in-vitro diagnostics and medical devices. In addition, the successful candidate will participate on the internal

auditing team and support rest of world registrations as well as participate in

company-wide compliance projects. The successful candidate will report in to

the position site Regulatory Head within the business unit.


Create Regulatory Planning for US and Global product


Provide regulatory guidance for and participate in new product development

and product changes

Interact with and coordinate with company employees world-wide to support

business unit objectives

Drive regulatory submissions, regulatory agency communications and other

tasks for compliance purposes

Guides the writing and filing of appropriate FDA pre market submissions

Review and approve project DHF

documentation for compliance with EU and FDA regulations ..

Supports the decision making process on regulatory submission issues using

historical knowledge, legal counsel and FDA's current regulations on medical

device industry.

Act as liaison with FDA and other regulatory agencies and site if needed

**Required Knowledge/Skills, Education,and Experience**

Minimum BA/BS in scientific discipline

RA representative on assay,

hardware and software product core teams

Highly developed writing and

interpersonal skills

10% travel required

Ability to interact and communicate efficiently with global regulatory

agencies, work on multiple teams and work independently

Working knowledge of common computer software applications (WORD, EXCEL,

Adobe Acrobat, etc)

**Preferred Knowledge/Skills, Education,and Experience**

BS degree in Engineering, Molecular Biology or Biochemistry preferred

Prior experience in in-vitro diagnostics highly preferred

Knowledge of IVDD Harmonized

Standards preferred

RAPS Regulatory Affairs

Certification preferred


**Equal Employment Opportunity Statement**

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Financial Services
  • Healthcare
  • Biotechnology / Science
  • Legal
  • Engineering

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Technical Specialist 3

Berkeley, CA

Share this job

Regulatory Technical Specialist 3

Berkeley, CA

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast