Why RA/QA 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

We are currently seeking a Senior Regulatory Affairs Specialist to join our Joint Replacement Division. This role will be hybrid in Mahwah, NJ.

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and 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.

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 Regulatory Affairs Specialist, you will operate in a fast-paced environment and liaise with internal customers and external regulatory authorities to maintain regulatory compliance of Joint Replacement implant and instrument products globally.

• Possess and apply knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain compliance of a large portfolio of Joint Replacement implant and instrument products

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

• Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval of device modifications

• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

• Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

• Maintain and update EU technical documentations and support technical surveillance audit.

• Assess global impact of changes to launched products. Author and support notifications/submissions.

• Evaluate changing medical device regulations and develop strategies for maintaining products on the market.

• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies.

• Advise and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance on quality, pre-clinical and clinical requirements

• Review labeling, marketing literature, and promotional materials for compliance with regulatory requirements.

• Review external standards for compliance assessment

What you need

• BS in Engineering, Science, or related degree required

• MS or RAC(s) preferred

• 3 years of experience in an FDA or highly regulated industry required

• 2+ years of Medical Device Regulatory Affairs experience required

• Strong project management, writing, coordination, and execution of regulatory items with emphasis on technical and scientific regulatory activities

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com