Company Overview
Dr. Langer Medical GmbH, based in Waldkirch, Germany, part of Brainlab in Munich since 2022, specializes in innovative medical technology for intraoperative neuromonitoring and neurostimulation with over 25 years of experience. Their products are award-winning and foundational to their global growth.
Job Description
You are interested in Regulatory Affairs or medical device development? As QM Consultant in the Regulatory Affairs team, you will work with Dr. Langer Medical departments, international partners, and global Regulatory Agencies. You will be part of a cross-functional team involved in product development and responsible for establishing regulatory strategies. This role entails interpreting regulatory requirements and implementing them in projects.
Your duties include:
- Collaborate in creating, updating, and reviewing technical documentation before and after CE marking for new or changed medical devices.
- Evaluate and follow design changes during development and implementation.
- Participate in product change documentation and change management.
- Discuss regulatory topics with R&D and other departments.
- Establish global regulatory strategies in collaboration with Brainlab subsidiaries' local partners.
- Compile regulatory submissions for authorities such as FDA 510(k), Notified Body, and others.
- Monitor and investigate regulatory requirements in predefined countries.
- Participate in and prepare for regulatory audits and follow up on improvement opportunities.
- Conduct regular market monitoring and prepare PMS/PSU reports.
- Train Dr. Langer Medical employees on regulatory requirements.
Qualifications
- Degree in medical engineering, life sciences, or related fields preferred; other degrees may be considered.
- Knowledge and experience with medical device regulations including EN ISO 13485, MDR (2017/745), FDA 21 CFR part 820 (QSR), and MDSAP.
- Professional experience in regulatory affairs or regulatory compliance for medical devices. Experience in R&D or related departments is a plus.
- Excellent English and proficient German communication skills, both written and verbal.
- Ability to communicate effectively with all stakeholders.
- Independent, structured, and pragmatic working style.
- Persuasive power.
Additional Information
- Supportive international team.
- Meaningful work impacting medical technology.
- 30 vacation days plus Dec 24 and Dec 31 off.
- Flexible working hours.
- Regular team and company events.
- Internal fitness program.
- Comprehensive training and education opportunities at Brainlab.
- Recognized as TOP 100 innovator and employer of the future 2022.
Ready to apply? Submit your online application including your earliest start date and desired salary.