Senior Analyst, Regulatory Affairs
New
J
JobgetherLife Sciences
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- Project ManagementCompliance
Requirements
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related discipline (Master's preferred).
- 5+ years of professional experience in Regulatory Affairs, Regulatory Intelligence, Quality, or Compliance within the medical device or IVD industry.
- Working knowledge of global medical device and IVD regulations, including FDA, EU IVDR, and ISO 13485.
- Proven experience conducting regulatory assessments and translating requirements into actionable recommendations.
- Experience managing or supporting compliance-related projects in cross-functional environments.
- Strong analytical and critical-thinking capabilities for interpreting complex regulatory information.
- Strong written and verbal communication skills.
- Solid project management and organizational skills.
- Experience using regulatory intelligence platforms, compliance databases, or digital tools.
Responsibilities
- Monitor and track global regulatory developments affecting IVDs, medical devices, software, AI-enabled products, and chemical/environmental compliance frameworks.
- Conduct regulatory intelligence assessments and translate regulatory changes into clear summaries of potential impacts.
- Maintain regulatory intelligence databases, dashboards, and communication tools.
- Prepare regulatory impact assessments and support regulatory change management activities.
- Collaborate with cross-functional stakeholders to coordinate timely responses to regulatory changes.
- Develop and deliver periodic regulatory intelligence reports and management updates.
- Leverage digital and AI-enabled technologies to improve regulatory monitoring and knowledge management.
- Support regulatory inspections, audits, and broader compliance initiatives.
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