Senior Regulatory Affairs

Job description
Division: Spine Job title: Senior Regulatory Affairs 
Specialist
Function: Regulatory Affairs Travel: 10%
Location: 
(City, State or Country) Bangalore/Gurgaon
People 
manager: No
Position summary: 
This position will be responsible for:
• Planning, organizing and implementing strategies and activities required to procure regulatory 
approval for new and revised product lines under the guidance of more senior regulatory 
professionals.
• Ensuring compliance to all US, EU and Spine requirements and corporate policies and 
procedures regarding submissions and other requirements for market approval of medical 
devices/combination products.
• Participating in cross functional team activities from initial stages through securing government 
approvals. 
• Applying scientific principles to understanding safety and efficacy on a wide range of products
Essential duties & responsibilities: (detailed description)
• Participate on product development teams to insure US and EU regulatory requirements are 
incorporated as part of the development process
• Author submissions and other regulatory documents to obtain approval to bring new or modified 
products to market
• Assist in post market submissions (progress reports, annual reports etc.)
• Support marketing, R&D and manufacturing teams in regulatory assessment of proposed 
changes or product transfers
• Address and advise teams on appropriate pathways to market under the supervision of more 
experienced regulatory professionals
• Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other 
regulatory agencies on submissions, approvals or other issues under the supervision of more 
experienced regulatory professionals
• Establish and maintain regulatory information systems both electronically and hard copy
• Interpret existing and/or new regulatory requirements as they relate to company products and 
procedures. Communicate this to appropriate personnel
• Review and approve product and manufacturing changes while considering both US and EU 
regulatory requirements
• Prepare and update US product listings and EU registrations
• Communicate any FDA correspondence on submissions to the appropriate team(s) and RA 
management
• Conduct labeling, marketing, product transfer and literature review pre and post market under 
the supervision of a more experienced regulatory professional
• Prepare Technical files and Design Dossiers to support CE Marking under the supervision of a 
more experienced regulatory professional
• Assist the RA Managers and others with the development, implementation and maintenance of 
regulatory SOP's
• Participate in other regulatory projects as assigned
Education & special trainings:
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proprietary. Neither this document nor the information herein may be reproduced, used, or 
disclosed to or for the benefit of any third party without the prior written consent of Stryker.

• Bachelor’s Degree or equivalent combination of education and experience, required; RAC 
certification preferred
Qualifications & experience:
• 510(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plus
• Minimum 1-year experience in FDA regulated industry
• Working knowledge of Medical Device Regulations (FDA and EU required)
• Direct interaction with FDA reviewers/inspectors
• Team based work environment experience preferred
• Strong interpersonal, written, oral, communication, organizational and planning skills
• Working knowledge of personal computer systems and desktop office applications
• Sound understanding of scientific principles
Physical & mental requirements: 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 
Requirements listed here are representative of knowledge, skill, and/or ability required. Reasonable 
accommodations may be made to enable individuals with disabilities to perform essential functions.