Lead RA at Stryker - Poland

Gurugram, haryana, India -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Intelligence, Risk Anticipation, Product Classification, Regulatory Submissions, Health Authority Interactions, Scientific Documentation Review, Cross-functional Collaboration, SOP Development, Compliance Strengthening, Project Management, Decision Making, Inclusive Leadership, Technical Writing, Regulatory Affairs Certification, Quality Systems

Industry

Medical Equipment Manufacturing

Description

Work Flexibility: Onsite Key Areas of Responsibility: Translates regulatory intelligence into actionable local, regional, and global regulatory strategies aligned with business goals. Anticipates regulatory risks and emerging issues, offering proactive, solutions‑oriented guidance throughout the product lifecycle. Evaluates products for classification, jurisdiction, and market‑access requirements, identifying the most efficient regulatory pathways. Provides technical regulatory input across quality, preclinical, clinical, and manufacturing teams to ensure compliance. Leads regulatory submissions end‑to‑end—planning, preparing, submitting, and managing interactions with global health authorities. Reviews scientific documentation (quality, preclinical, clinical) for completeness, accuracy, and regulatory acceptability. Collaborates effectively with cross-functional teams, supporting meetings with regulatory authorities and advisory committees. Develops and enhances regulatory SOPs, strengthens compliance, and trains stakeholders on evolving regulatory expectations. Manages complex regulatory projects with autonomy, strong organization, and sound decision‑making. Demonstrates inclusive leadership, embracing diverse perspectives and supporting the development of Specialists/Sr. Specialists. Adapts to challenging assignments, navigates organizational dynamics, and continuously builds regulatory expertise. Qualifications Bachelor’s degree in Engineering, Science, or related field; Master’s in Regulatory Science preferred 4+ years of regulatory affairs experience in healthcare, medtech, pharma, or related regulated industries Regulatory Affairs Certification (RAC) is a plus Strong understanding of regulatory pathways, compliance, submissions, quality systems, and post‑market requirements Excellent communication, technical writing, and project management skills Ability to operate with autonomy, judgment, and cross‑functional influence Travel Percentage: 20% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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Responsibilities

This role involves translating regulatory intelligence into actionable global strategies and proactively managing regulatory risks throughout the product lifecycle. Key duties include leading end-to-end regulatory submissions, providing technical input across various teams, and ensuring compliance with health authority requirements.