PHARMAFull-time
Senior Regulatory Affairs Specialist
By Admin · Regulatory Affairs
BANGALORE (IN)HYBRIDPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONSTRYKERMedical Technology / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
Join Stryker's Ortho Tech Division as a Senior Regulatory Affairs Specialist supporting regulatory activities for a broad portfolio of orthopedic instruments.
Support regulatory compliance, submission activities and regulatory intelligence to help products meet global market requirements.
Work with cross-functional teams in a highly regulated medical-device environment.
Core Regulatory Responsibilities
Monitor regulatory requirements, guidance documents and applicable industry standards across global markets.
Research and compile regulatory requirements, approval pathways and compliance information for products and programmes.
Collect, organise and maintain regulatory intelligence files, submission documentation and supporting records.
Assist with preparation of regulatory dossiers, pre-submission packages and submission materials for regulatory agencies.
Track regulatory submissions and applications under review and provide status updates to stakeholders.
Maintain records of communications, regulatory commitments and outcomes involving regulatory authorities and other stakeholders.
Coordinate meeting logistics and prepare supporting materials for regulatory-agency discussions and internal meetings.
Organise and support review of preclinical, clinical, quality and technical documentation required to meet regulatory requirements.
Technical & Domain Expertise
Bachelor's degree required, preferably in Engineering, Science, Regulatory Science or another related technical field.
The posting specifies 6-10 years of work experience for the preferred technical-field profile.
Demonstrated ability to work with technical, scientific or regulated documentation through academic, internship, co-op or professional experience.
Preferred Master's degree in Regulatory Science or a related discipline.
Preferred experience supporting Regulatory Affairs, Quality, Clinical, Research or Compliance activities within a regulated industry.
Familiarity with medical-device, pharmaceutical, biotechnology or other regulated-industry regulations and standards is preferred.
Cross-Functional Impact
Partner with internal stakeholders to gather and organise technical, clinical, preclinical and quality information for regulatory purposes.
Provide regulatory intelligence that supports product-market requirements and compliance decisions.
Help maintain accurate regulatory records and ensure submission activities remain organised and traceable.
Support communication and coordination between regulatory teams, internal functions and regulatory authorities.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Regulatory Compliance
Regulatory Intelligence
Regulatory Requirements
Global Regulatory Requirements
Regulatory Submissions
Regulatory Dossiers
Pre-Submission Packages
Regulatory Documentation
Approval Pathways
Medical Devices
Orthopedic Instruments
Technical Documentation
Scientific Documentation
Quality Documentation
Clinical Documentation
Preclinical Documentation
Industry Standards
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Stryker is one of the world's leading medical technology companies, offering a diverse range of innovative products and services. They specialize in Orthopaedics, Medical and Surgical (MedSurg), and Neurotechnology and Spine. The company works closely with medical professionals to deliver solutions that improve patient outcomes and hospital efficiency.
TEAM SIZE: 50,000+ employees
INDUSTRY: Medical Technology / Healthcare
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.