Regulatory affairs manager - Prague

As the Senior Regulatory Affairs Specialist for Medical Devices, you will play a pivotal role in ensuring our products meet all regulatory requirements and standards. You will lead regulatory strategies, submissions, and compliance activities for our diverse range of medical devices, from conception to market entry and post-market surveillance. This is a unique opportunity to make a significant impact on the healthcare industry by helping to bring innovative medical devices to patients around the world.

What will be your key responsibilities:

Your key responsibilities will be to:

Develop and implement regulatory strategies for new and existing medical devices.
Prepare and submit regulatory filings.
Ensure compliance with related institutions.
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory compliance at all stages of product development.
Stay up-to-date with changes in regulations and industry standards and communicate their implications to the organization.
Oversee post-market surveillance and reporting activities.

What experience should you have:

Bachelor's degree; advanced degree preferred.
3+ years of regulatory affairs experience in the medical device industry.
Strong knowledge medical device regulations.
Proven success in preparing and submitting regulatory filings.
Excellent communication and interpersonal skills.
Ability to work effectively in a cross-functional team environment.
Detail-oriented with strong analytical and problem-solving skills.

What do you get in return:

Opportunity to work with cutting-edge medical devices that improve patient lives.
Competitive salary and benefits package.
A collaborative and innovative work environment.
Career growth and development opportunities.

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