Specialist/Sr. Specialist Regulatory Affairs

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Sets direction.An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.

Builds organizational capability.A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.

Inspires others.A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.

Champions talent development.A manager who focuses on maximizing the ability, potential and contributions of themselves and others.Fosters an environment where people can excel through developing, coaching and rewarding performance.

Delivers results.A driven player/coach who sets high goals for personal achievement and organizational success.He/she measures success against the best internal and external benchmarks.

What you will do

• Evaluating regulatory impact of proposed changes to launched products.

• Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.

• Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

• Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Project management, writing, coordination, and execution of regulatory items.

• Completing technical and scientific regulatory assignments that are broad in nature.

• Assisting in SOP development and review.

• Assisting in the development and update of regulatory strategy based upon regulatory changes.

• Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.

• Determining and communicating submission and approval requirements.

• Participating in risk-benefit analysis for regulatory compliance.

• Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

• Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.

• May be required to provide regulatory input to new product development and product lifecycle planning.

What you need:

• Bachelor’s or Master’s degree in Regulatory Affairs, Engineering or equivalent discipline is required.

• Medical Device industry experience is preferred.

• 3 - 5 years experience in an equivalent position within an R&D environment is preferred

• Experience with post-market and change management is a distinct advantage

• RAC Certification is preferred

Our benefits

Our total rewards offering varies by country but often includes 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.

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/