As a Regulatory Affairs Compliance Officer at SRG's partner biotechnology company, you will play a vital role in ensuring adherence to regulatory requirements.
Job Description:
Implement and maintain regulatory compliance processes, including post-market surveillance and vigilance, to guarantee quality and safety standards are met.
Responsibilities:
* Develop and maintain effective relationships with regulatory bodies and external entities
* Monitor and respond to regulatory updates and changes
* Ensure compliance with relevant directives, regulations, and standards (e.g., 93/42/EC, 98/79/EC)
* Prepare and submit reports as required by competent authorities
* Collaborate with cross-functional teams to address regulatory queries and concerns
Key Skills and Qualifications:
* Scientific degree in a relevant field
* Proven experience in regulatory affairs within medical devices/IVD
* Familiarity with FDA-regulated environments and industry-specific regulations
* Excellent communication and negotiation skills
What We Offer:
* Competitive salary and benefits package
* Ongoing training and development opportunities
* A dynamic and supportive work environment