Regulatory Affairs

Job Details

* Company: Lexium Consulting
* Position: Executive – Medical Device Regulatory Affairs
* Department: Regulatory Affairs
* Location: Thane & Nearby Areas
* Qualification: B.Pharm / M.Pharm / B.Tech / Biotechnology / Life Sciences
* Experience: 2–5 Years
* Employment Type: Full-Time (On-site)

🚀 Career Opportunity | Executive – Medical Device Regulatory Affairs

Take the next step in your Regulatory Affairs career with an exciting opportunity in the Medical Device industry. We are looking for skilled professionals with experience in global regulatory submissions, quality management systems, and medical device compliance.

Key Responsibilities

* Prepare and manage regulatory submissions for medical devices.
* Handle technical documentation, gap assessments, and regulatory compliance activities.
* Support global regulatory submissions and product registrations.
* Implement and maintain Quality Management System (QMS) documentation.
* Conduct risk management activities in accordance with applicable standards.
* Coordinate with clients, regulatory authorities, and testing laboratories.
* Ensure compliance with applicable medical device regulations and quality standards.

Required Skills

* Strong knowledge of Medical Device Regulatory Affairs.
* Experience with CDSCO, EU MDR, US FDA 510(k), and ISO 13485 requirements.
* Familiarity with risk management principles and regulatory documentation.
* Excellent technical writing, documentation, and communication skills.
* Strong analytical, organizational, and problem-solving abilities.
* Ability to work effectively with cross-functional teams and external stakeholders.

Disclaimer: FYND Talent Solutions is an independent recruitment platform. This job is shared for informational purposes only and is not an official communication from the hiring company unless explicitly stated.

Apply Now-info@lexiumconsulting.com

Share This Job

WhatsApp FacebookX Twitter LinkedIn TelegramMail