Job Information
Stryker Senior Clinical Regulatory Specialist in Bengaluru, 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.
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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.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future 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
What you will do:
The main objective of this role is to drive market access in Australia by providing technical support for the creation, review and finalisation of clinical evaluation documentation needed for the registration of medical devices in the Global market.
This role will work closely with Stryker Design Divisions and the Stryker South Pacific Regulatory and Market Access team to achieve this goal.
All aspects of the role must be in compliance with company policy as well as meeting internal and external customer demands.
Key areas of accountability/responsibility:
Thorough understanding of the global Clinical Evidence requirements for regulatory compliance in the European and Australian market.
Understanding of Europe's new Medical Devices Regulation (MDR 2017/745) and the US FDA regulatory pathways for medical devices.
Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met.
Completely review all existing documentation in support of meeting the applicable Essential Principles of the Regulation(s). Evaluate and identify gaps or deficiencies in documentation.
Determine applicable testing requirements and standards for subject device.
Review available clinical data, compile a comprehensive and compliant Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
Compile and/or review proposed labelling and Instructions for Use.
Assess global regulatory requirements and make recommendations based specific regions to management to ensure technical documentation is compliant to introduce to global markets.
What You Need
Critical Requirements (eg: skills, experience, qualifications):
Skills:
A minimum of 3+ years demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
Thorough understanding of the requirements of the new European Medical Device Regulation (EU MDR) and some understanding of the Australian Medical Device Regulations.
Extensive experience in Medical Writing and preparation of Clinical Evaluation Reports (CERs)
Experience with preparing USA Premarket Notifications [510(k)s] (desirable)
Excellent communication skills
Qualifications:
- Tertiary qualifications such as an undergraduate science or engineering degree or equivalent.
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.