Senior Specialist, Regulatory Affairs
Senior Specialist, Regulatory Affairs
Stryker
Job description
Company Description
Stryker is a medical technology company that makes products for MedSurg, Neurotechnology and Orthopaedics. The work that Stryker does helps improve care and makes healthcare outcomes better all over the world. The company helps than 150 million patients every year with its products and services. Stryker is famous for its award winning culture, good employee benefits and a real focus, on helping people have lives.
Job Summary
This role is part of the Smart Care team within Stryker's Regulatory Affairs group. As a Senior Specialist, you will support regulatory work across the full product lifecycle, including software, sustaining, and environmental activities. work closely with teams to review regulatory impact and offer guidance for product and business decisions. Regulatory impact will be a focus and provide guidance, for product and business decisions. The role is based in Portage, Michigan with a schedule.
Key Responsibilities
Help build, review, and maintain regulatory procedures and documents.
Support regulatory strategy and suggest updates based on new rules and standards.
Check compliance with global regulatory and environmental requirements.
Give regulatory input for new products, product changes, and lifecycle planning.
Study product history, classifications, and market details to guide regulatory decisions.
Spot possible regulatory risks and share findings with the wider project team.
Define the submission and approval requirements, for deliverables.
Participate in risk and benefit reviews to help shape product planning.
Educational Qualification and Skills Required
Bachelor's degree, preferably in Regulatory Affairs, Engineering, or Life Sciences.
At least 2 years of experience in regulatory affairs within a regulated industry.
Experience with software products or Software as a Medical Device is a plus.
Familiarity with environmental compliance and reporting is helpful.
Experience supporting products through their full lifecycle is a bonus.
Regulatory Affairs Certification (RAC) is preferred.
A Master's degree in a related field is an added advantage.
Career Development
This role gives you broad exposure to regulatory work across a full product lifecycle. Stryker supports long term growth through strong benefits, training, and opportunities to build a lasting career in regulatory affairs.
Salary Structure
The average salary for a Senior Regulatory Affairs Specialist at Stryker ranges from ₹13.1 Lakhs to ₹16.3 Lakhs per year in India.
How to Apply
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Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.