Regulatory Affairs Specialist

Stryker; Gurugram District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A global medical technologies company is seeking a Regulatory Affairs Specialist in Gurugram, India. The role involves ensuring regulatory compliance, supporting product lifecycle management, and conducting assessments for FDA submissions. The ideal candidate should have a Bachelor's degree in Regulatory Affairs or Engineering and 3-5 years of relevant experience. This full-time position offers an opportunity to contribute to innovative medical technology solutions.

Qualifications

• 3 - 5 years experience in Regulatory Affairs or related field.
• Understanding of regulatory and legal frameworks.
• Experience with post-market regulation is preferred.

Responsibilities

• Support product lifecycle through regulatory impact assessments.
• Ensure compliance with FDA and other regulatory bodies.
• Conduct thorough assessments and submit required documents.
• Develop and apply knowledge of regulatory requirements.

Skills

Regulatory compliance

Project management

Technical writing

Change management

Education

Bachelor's or Master’s degree in Regulatory Affairs or equivalent

Job description

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Join to apply for the Regulatory Affairs Specialist role at Stryker

• Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
• Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.
• Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.
• Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
• Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.
• Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.
• Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.
• Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.
• Determining and communicating submission and approval requirements.
  
  

What you will do

• Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
• Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.
• Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.
• Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
• Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.
• Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.
• Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.
• Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.
• Determining and communicating submission and approval requirements.
  
  

What you need:

Required-

• Bachelor's or Master’s degree in Regulatory Affairs, Engineering or equivalent discipline is required.
• 3 - 5 years experience
  
  

Preferred-

• Experience with post-market and change management is a distinct advantage
• RAC Certification is preferred
  
  

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing

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