Specialist Regulatory Affairs

Stryker; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading company in medical technology is looking for a Regulatory Affairs Specialist to manage product lifecycle compliance and support the introduction of new products in both domestic and international markets. You will assess regulatory impacts, develop strategies, and ensure conformity to FDA and other regulatory body requirements. This role offers the opportunity to work autonomously while making significant contributions to product developments and compliance initiatives.

Qualifications

• 3 - 5 years experience in an equivalent position within an R&D environment preferred.
• RAC Certification is preferred.
• Understanding regulatory requirements and ability to communicate implications.

Responsibilities

• Assess regulatory impact of changes to products post-launch.
• Support new product development and update regulatory strategies.
• Complete thorough regulatory assessments and submissions.

Skills

Regulatory Documentation

Project Management

Relationship Management

Risk Management

Communication Skills

Attention to Detail

Education

Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent

Tools

Adobe Acrobat Professional

Microsoft Office Suite

Structured Product Labeling Software

Job description

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 Masters degree in Regulatory Affairs, Engineering or equivalent discipline is required. 3 - 5 years experience in an equivalent position within an R&D environment is preferredPreferred- Experience with post-market and change management is a distinct advantage RAC Certification is preferred,

Sign-in & see how your skills match this job

Sign-in & Get noticed by top recruiters and get hired fast

Regulatory Documentation, Regulatory Requirements, Relationship Management, Risk Management, Project Management, Adaptability,Product Launches, Regulatory Policies, Regulatory Inspections, Regulatory Strategies, Verbal , Written Communication, Organizational Skills, Attention to Detail

technical support, systems, adaptability, analytical, food industry, science, business, project management,regulatory affairs officer, manufacturing/production/process

Quality Reviews, Project Management, Communication Skills, Adobe Acrobat Professional,Labeling, US FDA labeling regulations, Drug Listing, FDA Regulations, eCTD Submission Standards, Microsoft Office Suite, Structured Product Labeling Software

ANDA, Pharmaceutical Industry, Biotechnology, Microsoft Word, Microsoft Excel, Adobe Acrobat Professional,Labeling, US FDA regulations, 505b2, eCTD submission, Medical Device Industry, Microsoft Office Suite

Regulatory Documentation, Regulatory Requirements, Relationship Management, Risk Management, Project Management, Adaptability,Product Launches, Regulatory Policies, Regulatory Inspections, Regulatory Strategies, Verbal , Written Communication, Organizational Skills, Attention to Detail

technical support, systems, adaptability, analytical, food industry, science, business, project management,regulatory affairs officer, manufacturing/production/process

Quality Reviews, Project Management, Communication Skills, Adobe Acrobat Professional,Labeling, US FDA labeling regulations, Drug Listing, FDA Regulations, eCTD Submission Standards, Microsoft Office Suite, Structured Product Labeling Software

ANDA, Pharmaceutical Industry, Biotechnology, Microsoft Word, Microsoft Excel, Adobe Acrobat Professional,Labeling, US FDA regulations, 505b2, eCTD submission, Medical Device Industry, Microsoft Office Suite

ACTIVELY HIRING

Regulatory Affairs Specialist Related Jobs