Regulatory Affairs Specialist (m/f/d)

Regulatory Affairs Specialist (m/f/d)

Permanent 

Location 01277 Dresden, Germany

 

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

 

The following challenges await you:

• In your role you will prepare and coordinate regulatory submissions and technical files for our new and existing products.
• You may interact directly with notified bodies on specific product submissions.
• The monitoring of relevant regulatory requirements will be your responsibility as well as direct interaction with the subject matter experts to ensure the performance of impact assessments.
• As the responsible person you will evaluate and approve proposed changes to products and controlled documents.
• The diligent preparation of vigilance reports and the cross functional communication will also be your responsibility.

Your profile:

• Bachelor’s degree in an Engineering discipline or related technical field required
• A minimum of 2 years experience in the field of rgulatory or R&D in the medical device industry are required.
• Proficient English language skills and basic German language skills needed.
• Strong communication skills to effectively liaise with regulatory agencies and internal teams.
• Ability to stay informed about changes in regulatory requirements and convey relevant updates to colleagues.
• Strong organizational skills to manage multiple projects and priorities.