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

Solid 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.

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