Senior Manager Clinical Affairs

• Define and lead the global Clinical Affairs strategy for Brainlabs global surgery portfolio ensuring alignment with product regulatory and commercial objectives / teams
• Lead and develop an international Clinical Affairs team responsible for clinical evaluation clinical research and scientific marketing communication
• Ensure clinical compliance with EU MDR FDA and other regulatory requirements
• Build and maintain a strong clinical network of investigators key opinion leaders and research partners
• Act as Process Owner for clinical evaluation and validation training authors and evaluators to ensure regulatory compliance
• Partner closely with R&D Product Management Marketing Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiation
• Bridge clinical research and scientific marketing by translating evidence into credible high-impact scientific and educational content
• Ensure GDPR compliance in clinical collaborations
• Define and manage clinical studies and investigations to support product innovation and regulatory approvals
• Represent the company in communications with regulatory authorities related to clinical strategy investigations and submissions

Qualifications :

• Advanced scientific medical or technical degree (PhD MD or equivalent preferred)
• Extensive experience in Clinical Affairs Clinical Research within the medical device industry
• Strong background in clinical and regulatory requirements for Class IIII medical devices
• Demonstrated leadership experience including managing international or cross-functional teams
• Several years of experience in Clinical Affairs Clinical Research and/or R&D within the medical device industry
• Clinical and regulatory background for Class I to Class III medical devices
• In-depth knowledge of EU MDR FDA regulations and Good Clinical Practice
• Hands-on experience in clinical studies clinical evaluations and regulatory submissions for medical devices
• Ability to translate clinical research into scientific marketing content
• Excellent stakeholder management communication and project leadership skills
• Solid understanding of GDPR and clinical data protection requirements
• Very good English skills German is a plus

Additional Information :

• A mutually-supportive international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days plus December 24th and December 31st
• Flexible working hours as well as hybrid work model within Germany
• Bike leasing via cooperation partner BikeLeasing
• Parking garage and safe underground bike storage
• Award-winning subsidized company restaurant and in-house cafes
• Variety-rich fitness program in our ultra-modern 360m2 company gym
• Regular after work team and company events
• Comprehensive training and continuing education opportunities

Ready to apply We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Géraldine Ferrer

Remote Work :

No

Employment Type :

Full-time

Key Skills
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Experience: years
Vacancy: 1