Senior Regulatory Affairs Specialist - 24184BR - EN in Fremont, CA at Stryker Corporation

Date Posted: 5/13/2018

Job Snapshot

Job Description

Stroke is one of the leading killers in most geographies across the globe. Stryker Neurovascular is focused on advancing the practice of less-invasive stroke therapies through our Complete Stroke Care™ solutions. Stryker NV is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke, and committed to providing Clinical education and support to help physicians deliver better patient outcomes. Stryker NV services over 68 countries around the world. As a result, the Regulatory team is large and covers a broad swath of geographies and products.
The NV Regulatory Affairs organization is organized into two major units: Domestic (U.S./EU/Canada) and International (support to ~60 additional countries). The Domestic team sits directly on R&D project teams and shapes the Regulatory/Clinical strategy for the project team. In addition, it handles ass submissions for the U.S., Europe and Canada. This powerhouse team produces between 300-400 submissions per year across the globe.

The NV Regulatory Affairs organization is leading the charge for stroke clinical research around the globe. Many that join the Stryker NV team state that the excitement level is similar to that as when cardiovascular devices took off 25 years ago. Stroke is severely underserved across the globe. Since Stryker NV invests more in stroke clinical research than any other entity in the world, this in turn drives significant projects for RA around the globe. U.S. FDA submissions are vast and cover every type of medical device submission possible. There presently are active PMAs, 510(k)s, HDEs, IDEs, De Novo submissions to name a few. Thus the department is a tremendous developmental ground for RA Specialists, Managers and leaders who want to grow and learn. If you want to contribute or even learn about neurovascular implantable devices, this is THE place to be.

This global team continues to have a multitude of ‘firsts’ in the space. For example, in the fall of 2016, this team managed producing the clinical evidence to obtain the first new indication for stroke in 20 years. This was achieved by working with the leading researchers for stroke based in Europe. Recently, in May of 2017, the DAWN trial was completed by this team opening up the treatment window for patients with large vessel beyond 6 hours from onset up to 24 hours. This has the potential to allow treatment a large percentage of an additional 300,000 victims/year in the world through device label expansion and related work.

This team is dynamic, high-energy and accomplished. Team members have challenging assignments and move quickly along in their career paths. Revolutionary submissions take place with high cadence across a myriad of devices including stent retrievers, coils, stents for adjunctive use with coiling, intracranial atherosclerotic stents, catheters, guidewires to name a few. Trial types include, HDE, IDE, PMA and other pre- and post-marketing studies. The developmental learning is abound and the opportunities are endless. This is the place to be in the Bay Area to advance your Regulatory career while engaging in our mission to fight stroke.

The Stryker NV Regulatory Affairs Team is determined to be #1 in the world for curing stroke. The team continues to push the boundaries of science and research. Do you have what it takes to change the world with this team?

The Senior RA Specialist typically has 2-3 years of industry experience, and reports to the RA Manager. The position includes the following opportunities:

  • Assist in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossiers and Certificates to Foreign Government. Ensures that existing approvals and documentation are maintained. Communicates with in-country RA personnel to facilitate global clearances/approvals.
  • Develop global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors.
  • Communicate with regulatory agencies
  • Evaluate proposed changes to products and controlled documents and upcoming regulations; recommends and implements global regulatory action plans based on changes. Organizes and maintains RA files.
  • Assist in performing basic to moderately complex research to support strategic planning.
  • Provides regulatory support to other Stryker and Stryker Personnel to facilitate cross-divisional leverage.
  • Understand: Stryker Neurovascular systems, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.

Job Requirements

  • Bachelor’s degree, preferably in a scientific or technical discipline.
  • 3+ years of Regulatory experience required
  • RAC Certification a plus

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