Regulatory Affairs Specialist

1d1 day ago

Oertli Instrumente AG

Sankt Gallen, CH · Full-time · CHF 95,000 – CHF 125,000

About this role

You are seeking a responsible position in Regulatory Affairs with international orientation. In this role you steer regulatory activities across global markets and accompany products through their entire lifecycle with high personal responsibility.

Core work includes creating and maintaining lean, complete and timely approval documentation while ensuring compliance with MDR, MDSAP and country-specific requirements. You prepare submissions, change and renewal applications and actively participate in conformity assessment procedures.

You communicate directly with authorities and service providers, integrate new regulatory requirements into existing processes and coordinate with multiple departments on interpretation and implementation. Global approval strategies for new products and ongoing maintenance of product files according to MDR form part of the varied scope.

The environment features an open Du-culture, family-like collaboration and an individually designed onboarding program with insight into different departments. Targeted training supports professional development while meaningful work improves patients’ lives.

Requirements

Completed degree in a relevant field such as Medical Technology, Life Sciences or Regulatory Affairs with initial experience in regulatory affairs for medical device approvals
First experience preparing and submitting medical device approval applications in multiple countries
Knowledge of EU-MDR regulations
Very good German and English language skills in spoken and written form
Independent, structured and solution-oriented working style
Ability to collaborate across departments with high initiative and decision-making capability

Responsibilities

Create and maintain lean, complete and timely approval documentation
Ensure compliance with MDR, MDSAP and additional country-specific regulatory requirements
Prepare and process approval applications, change and renewal applications for various countries
Handle regulatory change requests and participate in conformity assessment procedures
Identify and monitor country-specific and product-specific regulatory requirements
Communicate with authorities and service providers regarding approval activities
Integrate new regulatory requirements into existing processes and support cross-departmental implementation
Develop global approval strategies for newly developed products and maintain product files per MDR

Benefits

Open Du-culture and family-like working atmosphere
Detailed onboarding and individually designed introduction program with insight into various departments
Meaningful work that improves the lives of others
At least 5 weeks of vacation plus pre-holidays
Flexible working hours with option to work partly from home office
Targeted training and professional development support
Free parking and electric vehicle charging facilities
Free coffee, tea, fresh fruit and 15 minutes paid break