Home Jobs Senior RA Specialist
Back to Jobs

Senior RA Specialist - Job Opportunity at Hologic

Singapore, Singapore
Full-time
Senior
Posted: April 14, 2025
On-site
SGD 120,000 - 180,000 per year based on Singapore market rates for senior regulatory affairs positions in medical devices

Benefits

Career development in global medical device regulatory affairs
Exposure to multiple ASEAN markets
Professional development through regulatory certifications
International business environment

Key Responsibilities

Lead regulatory strategy for ASEAN/South Asia market entry
Manage cross-functional regulatory communications and documentation
Drive regulatory compliance and business strategy alignment
Direct product registration projects across multiple territories
Maintain regulatory intelligence database and market monitoring
Provide strategic guidance to commercial teams

Requirements

Education

Bachelor's degree in pharmacy, biomedical sciences or related field; Postgraduate degree preferred

Experience

Minimum 5-years' experience within the medical device or IVDs industry

Required Skills

Knowledge of EU MDD/MDR and IVDR, US FDA regulations Strong analytical and critical thinking skills Problem-solving capabilities Cross-cultural communication Stakeholder management English proficiency Asian language proficiency (advantageous)

Certifications

Regulatory affairs certifications (desired)
Advertisement
Ad Space

Sauge AI Market Intelligence

Industry Trends

Increasing regulatory complexity in ASEAN medical device markets with harmonization efforts Growing focus on IVD regulation particularly post-COVID Rising demand for regulatory expertise due to MDR/IVDR implementation Expansion of digital health and AI-driven medical devices requiring new regulatory frameworks

Role Significance

Typically part of a regional regulatory affairs team of 5-10 professionals, with matrix reporting to commercial and corporate RA
Strategic leadership position with direct impact on market access and business growth in ASEAN/South Asia

Key Projects

New product launches in multiple ASEAN markets Regulatory strategy development for market expansion Process optimization for registration efficiency Compliance monitoring and risk mitigation

Success Factors

Deep understanding of ASEAN regulatory frameworks and their practical application Ability to balance commercial priorities with regulatory requirements Strong stakeholder management across cultural boundaries Strategic thinking and risk assessment capabilities

Market Demand

High demand due to evolving regulatory landscape and shortage of experienced RA professionals in ASEAN region

Important Skills

Critical Skills

Regulatory intelligence and strategy development Cross-cultural communication and stakeholder management Risk assessment and mitigation Technical documentation and submission management

Beneficial Skills

Project management methodologies Quality management systems Digital health regulations Change management

Unique Aspects

Opportunity to shape regulatory strategy across diverse ASEAN markets
Direct impact on business growth through market access enablement
Complex stakeholder environment requiring sophisticated management skills

Career Growth

2-4 years in role before advancement, depending on business growth and regional expansion

Potential Next Roles

Regional Head of Regulatory Affairs Director of Regulatory Affairs Global Regulatory Strategy Lead

Company Overview

Hologic

Global leader in women's health and diagnostic solutions with strong presence in medical imaging and surgical products

Fortune 1000 company with significant market share in diagnostic and medical device segments
Established presence in ASEAN with growth focus in emerging markets
Matrix organization with strong emphasis on compliance and innovation
Advertisement
Ad Space
Apply Now

Data Sources & Analysis Information

Job Listings Data

The job listings displayed on this platform are sourced through BrightData's comprehensive API, ensuring up-to-date and accurate job market information.

Sauge AI Market Intelligence

Our advanced AI system analyzes each job listing to provide valuable insights including:

  • Industry trends and market dynamics
  • Salary estimates and market demand analysis
  • Role significance and career growth potential
  • Critical success factors and key skills
  • Unique aspects of each position

This integration of reliable job data with AI-powered analysis helps provide you with comprehensive insights for making informed career decisions.