Regulatory Engineer – II

iLenSys Technologies Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

A global professional services company based in India is seeking a Regulatory Affairs Specialist to manage regulatory submissions for IVD products. The candidate will prepare and compile regulatory dossiers, engage with stakeholders, and ensure compliance with international standards. A strong background in Life Sciences, regulatory frameworks, and excellent communication skills are essential for this role.

Qualifications

• Demonstrated success in securing registrations for CE-approved IVD products.
• Hands-on experience with legal manufacturers for regulatory compliance.
• Strong understanding of IVDR and global regulatory requirements.

Responsibilities

• Prepare and submit regulatory dossiers for IVD product registrations.
• Participate in formulating regulatory strategies for country-specific requirements.
• Provide insights on regulatory updates impacting IVD products.
• Provide insights on regulatory updates impacting IVD products.
• Stay informed on global IVD regulatory frameworks, including CE marking, IVDR, and other international standards.
• Identify opportunities to improve submission efficiency and compliance workflows.

Skills

Regulatory compliance

Communication skills

Project management

Technical documentation

Communication with authorities

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree in a relevant discipline

Job description

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Do you struggle with Global Market Access and compliance management?

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.• Advanced degree (Bachelor’s or Master’s) in a relevant discipline is highly preferred.

About iLenSys

iLenSys is a global professional services company with leading capabilities in digital technology service. Combining unmatched experience and specialized skills across various industries, we are a trusted Digital Engineering and Enterprise Modernization partner, providing technology operations services and proven solutions that create a unique competitive advantage for our clients by enabling them to see beyond.

Job Summary

• Prepare, compile, and submit high-quality regulatory dossiers for IVD product registrations in target countries, ensuring adherence to local regulatory frameworks.
• Participate in formulating regulatory strategies tailored to country-specific requirements for IVD products.
• Act as a liaison between the legal manufacturer and importing unit to streamline regulatory processes and achieve timely approvals as assigned by manager and project team.
• Provide actionable insights and recommendations to internal stakeholders on regulatory updates impacting IVD products.
• Stay informed on global IVD regulatory frameworks, including CE marking, IVDR, and other international standards to anticipate and address compliance challenges.
• Continuous Improvement: Identify opportunities to streamline regulatory processes, improve submission efficiency, and enhance compliance workflows.

Key Experience

• Demonstrated success in securing registrations for CE-approved IVD products in multiple global markets (e.g., EU, USA, China, Japan, Australia).
• Hands‑on experience working with legal manufacturers and importing units within the same organization to achieve regulatory compliance.
• Experience interacting with regulatory authorities and notified bodies in multiple jurisdictions.
• In‑depth knowledge of IVDR (EU 2017/746), ISO 13485, ISO 14971, and global regulatory requirements (e.g., FDA, NMPA, PMDA, TGA).
• Proficiency in preparing and managing technical documentation for IVD instruments, reagents, and consumables.
• Strong understanding of labeling, packaging, and import regulations in target countries.
• Exceptional communication and interpersonal skills to engage with diverse stakeholders, including internal teams, and external partners.
• Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast‑paced environment.