Senior Staff Regulatory Affairs Specialist in Fremont, CA at Stryker Corporation

Date Posted: 9/7/2019

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 Staff Regulatory Affairs Specialist to join our Neurovascular division to be based in Fremont, CA or remotely anywhere within the United States.

Who we want

  • Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues. ​
  • Achievers. Thrives on accomplishing tasks and constantly driven to do more. ​
  • Collaborators. Collaborates and builds relationships with internal and external stakeholders. ​
  • Communicators. Articulates well and expresses ideas effectively. ​
  • Learners. Great desire to learn and looks to continuously improve. ​
  • Teammates. Supports, encourages, and inspires others. ​

What you will do

As the Senior Staff Regulatory Affairs Specialist, you will develop and execute global regulatory strategy for new and/or modified medical devices to gain approvals for clinical investigations and commercial distribution.  This critical role advises project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements. Additionally, as the Staff Regulatory Affairs Specialist you will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development, submissions and follow-up on submissions under review (510(k) submissions). ​​

  • Lead the business unit in development of processes/procedures for and implementation of new or revised regulatory requirements. ​
  • Partner regularly with marketing, engineering, clinical and quality on project and product development teams. ​
  • Provide strategic direction on how to best streamline department processes (i.e. global regulatory submissions and registrations) ​
  • Serve as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities. ​

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Engineering, Science or related​ discipline required.
  • A minimum of 7 years’ experience in an FDA regulated medical device environment​ required.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred​.
  • Demonstrated success in management of global regulatory submission activities​.
  • Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. 93/42/EEC (Medical Device Directive, etc.). ​
  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements​.
  • Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment​.
  • Strong interpersonal, written and oral communication skills​.
  • Good time and project management skills with the ability to multi-task​.
  • Strong leadership skills​.

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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