Job Information
Stryker Senior Medical Writer in Gurugram, India
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 (http://careers.stryker.com/referrals/)
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. (http:)
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.