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 SOPs
Participate in other regulatory projects as assigned
Education & special trainings:
Stryker Confidential This document contains information that is confidential and 
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.