Full Time

2 days ago

Indore Mumbai Pune, India Willware Technologies Full time

Company Name : Willware Technologies

Work Model: Full Time (On-Site)

Work Location: Pune

Experience : 3 to 6 Years

Role & responsibilities

Regulatory Strategy: Develop strategies for market access and regulatory approvals.

Regulatory Compliance: Ensure medical devices comply with EU MDR (2017/745) and other relevant regulations.

Technical Documentation: Prepare and maintain Technical Files

Regulatory Submissions: Handle CE Marking, Notified Body interactions, and EU registrations.

Post-Market Surveillance: Adverse events, vigilance reporting, and Periodic Safety Update Reports (PSURs).

Labeling & UDI Compliance: Ensure product labeling and Unique Device Identification (UDI) requirements are met.

Quality System Support: Work with ISO 13485 and Quality Management Systems (QMS).

Cross-functional Collaboration: Coordinate with R&D, Quality, and Manufacturing teams for regulatory compliance.

Qualifications & Skills:

Education: Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Pharmacy, or Regulatory Affairs.

Experience: 3-5+ years in medical device regulatory affairs, preferably with EU MDR and NPD experience and have worked in OEM (preferred)

Knowledge:

Strong understanding of EU MDR, ISO 13485, and CE Marking processes.

Knowledge on LCM of Medical Devices.

Ensure effective communication throughout RA

Knowledge on Dossier creation, compilation and review, regulatory strategy and market launch of medical devices.

Communication: Excellent written and verbal communication skills for Notified Body interactions.

Attention to Detail: Ability to analyze and interpret regulatory guidelines.

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