Sr Staff Regulatory Affairs Specialist in San Jose, CA at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

Job Description

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 ​

The Regulatory Pre-Market team develops and executes global regulatory strategy for new and/or modified medical devices to gain approvals for clinical investigations and commercial distribution.  This critical function advises project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements .  Additionally, the  Staff Regulatory Affairs Specialist is responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development, submissions and follow-up on submissions under review.​

  • Opportunity to lead 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

  • Bachelor’s degree (B.S. or B.A.) in Engineering, Science or related​

  • 7+ years’ experience in an FDA regulated medical device environment​

  • 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: 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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team