Senior Manager Clinical Affairs
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
- 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
About Company
Brainlab revolutionized digital medical technology with the introduction of software for radiosurgery and surgical navigation. Today, Brainlab is an industry leader in digital surgery, radiotherapy and integrated operating rooms.Serving physicians, medical professionals and patients i ... View more
