About the Company: Our client is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field.

Job Overview: As a Regulatory Affairs Specialist , you will play a crucial role in ensuring that our client’s medical devices comply with all applicable regulations and standards across various markets. This role requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes. Your work will directly contribute to the global market access of innovative medical and aesthetic devices, ensuring product safety and regulatory integrity.

Key Responsibilities:

Ensure regulatory compliance of medical devices across different countries
Coordinate and prepare product registrations and notifications within deadlines
Communicate with regulatory authorities for product registrations and updates
Prepare and maintain technical files and other regulatory documents
Legalize documents and certificates through notary offices and embassies for product approvals
Provide support to customers with product data and regulatory information
Ensure compliance for product exports, including managing Certificates of Origin
Collaborate with marketing, purchasing, and engineering teams to meet regulatory requirements
Handle the issuance of Free Sale Certificates and other required regulatory documents
Support the registration of Economic Operators in the EUDAMED database
Translate regulatory documents between Slovak and English when necessary
Ensure compliance with organizational quality, environment, and health and safety standards

Requirements:

Academic degree in life sciences, chemistry, or technical/engineering education
2+ years of experience in a similar regulatory affairs position
Knowledge of regulatory issues and experience interfacing with local and international regulatory bodies
Advanced computer skills (MS Office)
Experience in medical writing is an advantage
English: Advanced (C1)
Slovak: Proficiency (C2)

Other Skills:

High attention to detail
Strong analytical and organizational skills
Excellent writing and communication skills
Team player with strong interpersonal abilities

What We Offer:

Competitive salary
13th salary in Q1 based on both company profits and individual employee performance
Reimbursement for commuting expenses
Great office environment and team culture
Long-term contract with the potential for growth

Join us and contribute to creating innovative products in a fast-paced, global environment!

Regulatory Affair Specialist