REGULATORY COMPLIANCE SPECIALIST

For over forty years, Intersurgical has been designing, manufacturing and supplying a wide range of quality respiratory products to hospitals all over the world.

 REGULATORY COMPLIANCE SPECIALIST To work in the Quality and Regulatory department at our Pabradė and/or Vilnius office 

ROLE OVERVIEW:

• As a Regulatory Compliance specialist, you will play a key role in reviewing, evaluating, and implementing of regulatory requirements for medical devices into Quality Management System processes.
• Working closely with Regulatory Compliance Manager, you will ensure that regulatory activities for manufacturing, quality and other business processes comply with relevant international standards, regulations and recommendations.
• This role requires a strong understanding of regulatory requirements related to the medical devices and the ability to identify, evaluate, and propose solutions for their implementation. You will monitor changes in medical device regulations and recommendations of different countries, assess changes and communicate their impact to the company’s departments.
• You will also coordinate projects related to the implementation of regulatory requirements, participate in meetings related to the regulatory area, and provide guidance and support to Product registration team regarding products registration activities in different markets.
• Additionally, you will collaborate with and advise company departments and customers on medical device regulatory questions or issues, and participate in internal and external audits within the scope of your competence.

• Higher/university education (law, medicine, pharmacy, engineering, or other related scientific studies);
• Knowledge of the regulatory requirements applicable for medical devices;
• Excellent written and spoken English and Lithuanian;
• Good communication skills;
• Attention to detail and accuracy in documentation and analysis;
• Proficiency with MS Office tools (Outlook, Teams, Word, Excel, etc.);
• Ability to work collaboratively across multiple departments;
• Willingness to adapt and take initiative.

PREFERRED SKILLS AND EXPERIENCE:

• Experience in the field of medical devices regulations or/and quality of medical devices.
• Understanding of regulatory requirements for medical devices according to European Union, MDSAP, or United Kingdom regulations and recommendations;
• Knowledge of Quality Management System principles according to ISO9001 and ISO13485 requirements;
• Experience in analysing and evaluating regulatory documents;
• Experience in project management;
• Experience in a regulated industry (medical devices, pharmaceutical etc.);
• Knowledge of Intersurgical processes and products;
• Knowledge of harmonised and international standards applicable to medical devices;
• Ability to read and understand technical documents related to medical devices.

• Become an important part of a growing international company;
• Engage in complex and meaningful work in Regulatory team;
• Access internal and external training opportunities;
• Experience a supportive and collaborative team environment;
• Competitive salary based on experience, knowledge, and skills (from 2100 to 2700 Eur/month before taxes);
• Annual appraisals;
• Timely holidays and no overtime;
• Free company transportation by bus to/from work (Vilnius-Pabradė-Vilnius only);
• Free gym access (Pabradė only).

Confidentially is guaranteed.

Please send your CV, marked Regulatory Compliance Specialist by 14th of February 2026 via CVMarket.lt system or to Personnel department, UAB Intersurgical, Arnionių 60, 18170 Pabradė.