Onsite
Posted 21 days ago
I'm Interested

Job Details

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 total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Know someone at Stryker?

Be sure to have them submit you as a referrral prior to applying for this position. Learn more about our employee referral program

This position requires professional mastery of a specialized field of regulatory expertise that typically requires a bachelor’s degree in engineering, Science, or equivalent focus or equivalent certification. Professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. Requires a minimum of 5 or more years’ regulatory or equivalent experience within a pharmaceutical and/or medical device company, or similar organization. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution, product development process, design control. Knowledge of application of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures. Knowledge of applicable international regulations and standards (CFR, EU MDR, QSR, ISO 13485, etc.) preferred. Judgement in applying professional expertise and is expected to work independently with minimal supervision. Requires attention to detail in making evaluative judgements based on the analysis of information. Advanced PC skills with proficiency in Microsoft Office Suite, including Excel.

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Mission
We're connecting diverse talent to big career moves. Meeting people who boost your career is hard - yet networking is key to growth and economic empowerment. We’re here to support you - within your current workplace or somewhere new. Upskill, join daily virtual events, apply to roles (it’s free!).
Are you hiring? Join our platform for diversifiying your team
Senior Medical Writer
I'm Interested