Regulatory Affairs Specialist 3

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Job Title:                                          Regulatory Affairs Specialist 3

Job Location: Berkeley, CA

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 Q-subs, 510(k) s and PMAs, EU technical files and renewals for in-vitro diagnostics assays and medical devices. In addition, the successful candidate will support interactions with the FDA 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.


Responsibilities

• Create Regulatory Planning for US and Global product submissions/registrations
• Provide regulatory guidance for and participate in new product development and product changes
• Drive regulatory submissions, regulatory agency communications and other tasks for compliance purposes
• Guide the writing and filing of appropriate FDA pre market submissions

• Review and approve project DHF documentation for compliance with EU and FDA regulations.
• Support 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
• Interact with and coordinate with company employees world-wide to support business unit objectives

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
• 4-7 years experience in in-vitro diagnostics

• 4-7 years experience with FDA submissions

• RAPS Regulatory Affairs Certification preferred

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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Job ID: 180895

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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