Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Baden Wuttemberg

Job Summary: As a Regulatory Affairs Specialist for one of the top 10 medical device companies in the world, you will be responsible for developing and executing regulatory project plans, ensuring compliance with all relevant regulatory requirements, and maintaining regulatory files.

Key Responsibilities:

• Maintain regulatory files in a format consistent with requirements.
• Maintain awareness of and identify relevant regulatory requirements.
• Participate as an active team member and provide regulatory advice to project teams as required.
• Respond to questions from regulatory authorities within strict timelines.
• Compile and submit regulatory documents in a timely manner according to regulatory requirements.
• Maintain and update existing regulatory authorizations.
• Support regulatory activities related to specific portfolio of products/projects.
• Prepare, review, and approve labeling and Standard Operating Procedures (SOPs).
• Represent or lead Regulatory Affairs in small project teams.

Qualifications:

• Experience in regulatory affairs within the medical device industry
• Strong understanding of regulatory requirements and guidelines.
• Excellent communication and organizational skills.
• Ability to work collaboratively in a team environment and independently when needed.
• Fluent English and German

If interested in this role please do click apply as i would be keen to speak.