Principal Regulatory Affairs Specialist - 28533BR - EN in San Jose, CA at Stryker Corporation

Date Posted: 6/2/2018

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.
Communicators. Articulates well and expresses ideas effectively.
Collaborators. Collaborates and builds relationships with internal and external stakeholders.
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. The Principal Regulatory Affairs Specialist advises business concept and product/ project development teams on regulatory pathway option(s) and requirements for clinical trials, new and/or modified devices, etc . This position will be responsible to prepare complex submissions and/or presentations to regulatory agencies and for any related communications. The Principal Regulatory Affairs Specialist shall also develop and mentor other regulatory affairs professionals within the department.
•Opportunity to participate in regulatory due diligence.
•Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either changes in the business or regulatory requirements.
•Prepare complex regulatory submissions and/or presentations (i.e. pre-submissions, IDEs, 510(k)s, Technical Files, etc.) to regulatory bodies (i.e. FDA, Notified Bodies, etc.) and for any related communications.
•Partner regularly with marketing, engineering, clinical and quality on business concept, project and product development teams
•Serve as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities

Job Requirements

What you need
•Bachelor’s degree (B.S. or B.A.) in Engineering, Science or related
•9-13 years’ experience in an FDA regulated medical device environment
•RAC certification or Advance Degree (Master in Regulatory Affairs) required
•Strong leadership skills
•Demonstrated success in management of global regulatory strategy and 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

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