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Senior Regulatory Affairs Specialist

Job Description

Company Background

Corindus, Inc., a Siemens Healthineers Company is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision and workflow.

Position Summary:

This position reports to the Sr. Manager of Regulatory Affairs, and is responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets.  The Sr. Regulatory Affairs Specialists works with the regulatory and clinical teams to develop and implement regulatory and clinical strategy to get precision robotic systems through various regulatory agencies. As part of a multi-disciplinary group, this position also contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.

Primary Responsibilities:  

  • Work with the Sr Manager of Regulatory Affairs to determine effective regulatory strategies across a variety of projects and issues
  • Work 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

Qualifications:

  • Bachelor’s in Engineering or Science required. Advanced degree preferred.
  • At least 3 years of experience in regulatory affairs in the medical device, biotech or pharmaceutical environment
  • Regulatory compliance experience in the medical device area preferred
  • Knowledge of applicable US and EU medical device regulations required. Knowledge of other markets is preferred
  • Regulatory submission experience in US and EU, including but not limited to 510(k), PMA, DeNovo, Technical Files, STED
  • 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

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:

1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR

2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.

(Note: Accommodations may be requested for certain medical or religious reasons)

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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Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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