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Staff Regulatory Affairs Specialist in Fremont, CA at Stryker Corporation

Date Posted: 1/12/2019

Job Snapshot

Job Description

Seeking energetic, results-driven regulatory professional for exciting, high impact opportunity to work on projects that make a difference in the world.

An Opportunity to Make a Difference in the World

If you’re a results-driven Regulatory professional looking to make a difference in the world, consider why Stryker may be right for you:

  • 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; #21 in 2016. 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 diverse field medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
  • 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.

    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 neuro-technologies 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. http://stroke.ahajournals.org/content/early/2015/06/26/STR.0000000000000074.full.pdf+html?sid=f235b97e-c39d-4307-906f-5d6923f96f32
  • We were recently recognized in 2016 as at Top Work Place in the Bay Area by the Bay Area News Group.

Experience Required:

  • Professional certification(s) preferred.
  • Typically a minimum of 4 years of Regulatory Affairs medical industry experience, preferably with medical devices.
  • Thorough understanding of FDA and international medical device regulations.
  • General understanding of regulations applicable to the conduct of clinical trials.
  • General understanding of product development process and design control.
  • Effective research and analytical skills.
  • Proficiency with Microsoft Office.
  • Ability to manage multiple projects.
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision.

Responsibilities:

Under general supervision of the RA Project Manager or RA Department Manager or Director.

  • Prepares 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, Certificates to Foreign Government.  Ensures that existing approvals and documentation are maintained.  Communicates with in-country RA personnel to facilitate global clearances/approvals.
  • Develops 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, and proactively shares this information.
  • For new, routine or ongoing issues, communicates with regulatory agencies.   Prepares for meetings with regulatory agencies and investigators.
  • Mentors others on a regular basis.  Is not expected to supervise others.
  • Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes.  Organizes and maintains RA files.
  • Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to:  standards, guidelines, regulations, and regulatory approvals/clearances.
  • Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage.
  • Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Stryker’s Quality System.  Prepares and delivers training programs to the department and other functional groups to ensure compliance.
  • Understands: Stryker’s systems, biocompatibility requirements, CMDRs, 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.
  • Uses existing project management tools and develops/implements new tools as needed.
  • Performs responsibilities required by the Quality System and other duties as assigned or requested.

Work From Home: No

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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