Senior Regulatory Affairs Specialist in Fremont, CA at Stryker Corporation

Date Posted: 9/4/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Regulatory Affairs Specialist to join our Neurovascular Division to be in Fremont, CA.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business 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. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the  FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Senior Regulatory Affairs Specialist you will perform product configuration management tasks to support business on new product introduction and product change. You will provide support on submissions publications for regulatory submissions to Regulatory Agencies in the US, Canada and Europe and other International Regions.

  • Manage and transact data between several company systems keeping the database as source of truth for various internal clients.
  • Execute product holds and releases actions in a timely manner to assure business continuity and avoid back orders
  • Assist in creating and executing relevant RA metrics to support strategic planning.
  • Author SOP/Work Instructions related to scope of work.
  • Uses existing systems and procedures and recommends solutions and/or improvements. 
  • Provide professional representation of RA in cross functional projects and multifunction boards, serving as product configuration management SME.
  • Provide support on Change Notifications, Device Notifications, UDI submission to FDA and NC/CAPAs for Domestic and International RA.
  • Experience working on systems & process change implementation projects.
  • Ability to make the complex or ambiguous understood to the business in communications, training and status updates to the business.
  • Hold self-accountable to deliver on tasks & meet business deadlines.
  • Organizes and maintains RA files such as Responsibilities Matrix, Certificates from Notified Bodies (CFS and CFG) and other RA related material.
  • Provide document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Japan, Canada, and International.
  • Assists in preparing 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.
  • Performs responsibilities required by the Quality System and other duties as assigned or requested.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Legal, or Regulatory or related​ discipline required.
  • A minimum of 3 years of experience in a FDA regulated industry required.
  • A minimum of one year in a Regulatory Affairs role required.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents preferred.
  • Experience with international regulations preferred.
  • Understanding of the FDA device listing and establishment registration process preferred.
  • Complying with constantly changing regulatory procedures; reprioritizing work effectively.
  • Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.).
  • Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Must possess excellent oral and written communication skills.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Ability to communicate and network with regulatory personnel to obtain relevant information.
  • Excellent analytical and writing skills.

Work From Home: No

Travel Percentage: 10%

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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