Senior Staff Quality Specialist, Regulatory Post Market Surveillance (Remote) (R464880)
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.Why join Stryker?
We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
Why regulatory affairs/quality assurance at Stryker?
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Stryker is seeking to hire a Senior Staff Quality Specialist- Regulatory Post Market Surveillance to join our Enabling Technologies unit within the Spine Division. This role is remote, and candidates can live anywhere in the United States.
WHO WE WANT:
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
WHAT YOU WILL DO:
As a Senior Staff Quality Specialist - regulatory post market surveillance you will be responsible to lead our regulatory compliance program for our Airo TruCT device Mobius Imaging | Stryker. Main responsibilities include driving the evaluations of potential non-conforming product and software changes, drive organizational decisions on product field actions through completion of Health Hazard Evaluations and compliance assessments, shaping and improving the process by owning local procedures. To be successful in this role this individual possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.
WHAT YOU WILL DO:
Maintain the regulatory compliance program at the division by developing and planning recall strategies and effectively managing and executing recalls and compliance assessments
Perform all activities, communication and documentation required to conduct and conclude a field action in the US and assist with OUS field action execution.
Notify/interact with FDA and other regulators on reportable field actions and follow up of all required documentation.
Ensure timely completion of recall activities and communication with regulators and third parties
Represent the post market team during audits as an SME
Provide strategic input and guidance on regulatory requirements to cross functional teams
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
Develops and manages programs that train junior specialists and stakeholders (field/ marketing. QA) on current and new regulatory requirements to ensure organization-wide compliance
Provide data reports for various work stream as required
Maintain the product security post market surveillance requirements, planning and execution
Participate in special projects and perform other miscellaneous duties as required.
WHAT YOU NEED:
Bachelor’s Degree Required. Bachelor’s degree in engineering or science preferred.
7+ year related work experience in an FDA or regulated industry required.
Capital equipment and software medical device product experience required
Understanding of ERP systems (commercial holds, distribution reports, etc.)
In-depth knowledge of FDA and international medical device regulations and standards (CFR, MDR, ISO 13485, MDSAP, etc.)
This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com