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Principal Regulatory Affairs Specialist

Job Description

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.
 
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Principal Regulatory Affairs Specialist responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets for the Endovascular Robotics Division of Siemens-Healthineers.
 
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
 
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.  We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.  

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Principal Regulatory Specialist you will be responsible for:
  • Determine effective regulatory strategies across a variety of projects and issues
  • Independently prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
  • Advise company stakeholders on regulatory strategy as part of the product development process
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
  • Review and approve Engineering Change Orders in accordance with regulatory requirements
  • Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
  • Review and approve test protocols to support regulatory submissions
  • Review device labeling and advertising material for compliance with submissions
  • Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
  • Maintain regulatory files
  • Perform internal audits of the Quality System
  • Analyze product complaints and make recommendations regarding their reportability
  • Other duties as assigned
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:
  • Regulatory compliance experience in the medical device area. Neuro experience preferred.
  • Knowledge of applicable US and EU medical device regulations required. Knowledge of other markets is preferred
  • Working knowledge of GMPs and GCPs required
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of regulatory terminology; additional knowledge of medical terminology desired
  • Proficiency in MS Office applications: Word, Excel, PowerPoint; web-based applications; Adobe Acrobat
Required skills to have for the success of this role:
  • Bachelors in Engineering or Science required. Advanced degree preferred.
  • Regulatory submission experience in US and EU, including but not limited to 510(k), PMA, DeNovo, Technical Files, STED 
  • At least 5 years of experience in regulatory affairs in the medical device, biotech or pharmaceutical environment
  • Willingness to travel 5-10% of the time
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.

Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.   

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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Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Experienced Professional

Full / Part time: 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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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