Principal Regulatory Affairs Specialist in Fremont, CA at Stryker Corporation

Date Posted: 11/5/2018

Job Snapshot

Job Description

Are you a Regulatory Affairs Professional looking for an exciting new opportunity and a chance to be involved with life-saving Neuro technologies?

At Stryker Neurovascular, the Principal Regulatory Affairs Specialist will:

  • Prepare complex submissions to gain approvals for clinical research, export, and commercial distribution.
  • Coordinate and prepare document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Japan, and Canada.
  • Ensure that existing approvals and documentation are maintained, including SAP Foreign Trade Status. Provide product information to the International Regulatory Affairs group to facilitate global clearances/approvals.
  • Develop global regulatory strategies for project teams. Provide input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies.
  • Monitor, research and obtain information on FDA clearances/approvals of competitors, and proactively shares this information with the Neurovascular project teams.
  • Communicate, plan, and execute meetings with regulatory agencies and investigators.

Why is this A Unique Opportunity?

Stay Engaged-  At Stryker Neurovascular, Regulatory Affairs is a truly dynamic place to be- with an opportunity to contribute to almost any type of medical device submission, including  510(k), IDE, HDE, De Novo, PMA and global submissions.  In terms of numbers- we generate 60-80 core submissions a year within US and EU, and close to 400 in International RA!

Go Global- We are a global business, with submissions going out to 72 countries, and have a significant regulatory presence in Asia, South America, Europe and many other regions.

Move and grow –there are many active job openings and opportunities within RA, with cross-training, job-shadowing, professional development offerings and active engagement with RAPS

Cross-pollinate!  Find opportunities to interface with clinical projects- currently Stryker has 12 sponsored studies. 

Save a life and make a difference- Stryker Neurovascular makes minimally invasive life-saving devices in the areas of ischemic and hemorrhagic stroke and ICAD- our products save lives every minute around the world and we hear directly from patients whose lives have been changed by our products.

An Opportunity to Reverse a Devastating Trend

  • At Stryker Neurovascular, our mission centers on Complete Stroke Care which aims to reverse the trend of 120,000 – a staggering 1 in 20 – US deaths caused by over nearly 800,000 US strokes per year.
  • We are the market leader in cutting edge, less invasive neurotechnologies that not only improved patient outcomes, but also led to double digit divisional and Stryker’s overall business growth.  Our stentriever technologies were proven with Class 1, Level A evidence to reduce death and disability in 5 recent, landmark clinical trials that spurred a major overhaul of the ASA/AHA Guidelines for treating acute ischemic stroke. We were recently recognized in 2015 as at Top Work Place in the Bay Area by the Bay Area News Group

A High Impact Leadership Opportunity

  • The Regulatory Affairs Specialist at SNV has a key position on product development and sustaining engineering teams- responsible for outlining global regulatory strategies, providing critical feedback on engineering changes, and liaising with project teams and the RA team at large. Opportunities to present new learning, participate in pilot programs, and mentor or shadow within the RA organization. 

Our Regulatory Affairs Specialists also:

  • Evaluate and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes.
  • Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
  • Sit on strategic planning teams.
  • Analyze existing systems and procedures, recommend solutions/improvements, and write work instructions and standard operating procedures as needed to support departmental functions and Quality System.

You MUST have:

  • Bachelor’s degree or equivalent work experience. (Preferably 8+ years Regulatory Affairs medical industry experience.)
  • Demonstrated success in management of regulatory submissions activities.
  • Thorough understanding of US and EU regulations.
  • Strong technical knowledge of medical products.
  • Strong technical understanding of relevant procedures, practices, and associated medical terminology.
  • Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
  • Thorough knowledge of product development process and design control.
  • Excellent written and oral communication, technical writing and editing skills.
  • Effective research and analytical skills.

You MIGHT ALSO have:

  • A degree in a scientific or technical discipline.
  • Professional certification(s), such as RAC.
  • Knowledge of human physiology.
  • Knowledge of Health Canada or Japan medical device regulations
  • Foreign language proficiency.

About Stryker

  • Stryker is a Fortune 400 company and one of the world’s leading medical technology companies with 35 years of sales growth, nearly $10B annual sales and more than 26,000 employees working in 100+ countries.  
  • Fortune Magazine has named Stryker a Most Admired Company in Medical Products and Equipment since 2005 and a Top 100 Places to Work for five consecutive years; climbing to #19 in 2015.  We are 1 of only 5 companies awarded Gallup Great Workplace Award 7 or more times, 
  • Our collective mission, together with our customers, we are driven to make healthcare better, and strong culture of innovation fuels our growth  We hold over 5,300 patents in a diverse field medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.  

Work From Home: Yes

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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