Bangalore, Gurgaon

Job ID: SS202400012

Function: Medical

Role: Senior Regulatory Affairs

Desired Skills: EU MDR, US FDA, MDD TO MDR Transition, Change Control

Job Description

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 skilled





- 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:
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.

📌 Senior Regulatory Affairs (India)
🏢 Saraca Solutions
📍 India