QM Consultant - Regulatory Affairs

JR Germany; Waldkirch; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

A leading company specializing in innovative medical technology seeks a QM Consultant in Regulatory Affairs. The role involves developing regulatory strategies for products, collaborating with international teams, and ensuring compliance with medical device regulations. Joining this internationally supportive team offers meaningful work and significant career development opportunities.

Leistungen

30 vacation days plus additional leave

Flexible working hours

Internal company fitness program

Comprehensive training opportunities

Regular company events

Qualifikationen

• Degree in relevant fields preferred.
• Knowledge of medical device regulations required.
• Excellent English and German communication skills needed.

Aufgaben

• Create, update, and review technical documentation for medical devices.
• Establish global regulatory strategies in collaboration with partners.
• Prepare regulatory submissions and monitor requirements.

Kenntnisse

Regulatory compliance

Communication

Technical documentation

Change management

Market monitoring

Ausbildung

Degree in (medical) engineering or life sciences

Tools

Medical device regulations knowledge

MDR (2017/745)

FDA 21 CFR part 820

Jobbeschreibung

QM Consultant - Regulatory Affairs, waldkirch

Client:

Dr. Langer Medical GmbH

Location:

Job Category:

Other

-

EU work permit required:

Yes

Job Views:

2

Posted:

15.07.2025

Expiry Date:

29.08.2025

Job Description:

Company Description

Dr. Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. It is therefore no coincidence that the products from Dr. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards.

Job Description

You are interested in Regulatory Affairs or in the development of medical devices? As QM Consultant in our Regulatory Affairs team you will interact with Dr. Langer Medical departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Dr. Langer Medical products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.

Your duties include:

• Collaboration on the creation, updating and review of the technical documentation before/after CE marking a new/changed medical device
• Evaluate and follow up design changes during the development and implementation
• Participation in the documentation of product changes - change management
• Discuss regulatory topics with R&D colleagues and other departments
• Establish global regulatory strategies for the medical devices of Dr. Langer Medical in collaboration with local partners of the Brainlab subsidiaries
• Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities
• Monitor & investigate regulatory requirements in pre-defined countries
• Participation and preparation of regulatory audits and follow up improvement opportunities
• Regular market monitoring and preparation of PMS/PSU reports
• Train Dr. Langer Medical employees in regulatory requirements

Qualifications

• Degree in (medical) engineering or life sciences preferred, but other degrees may be considered
• Knowledge and experience of medical device regulations such as EN ISO 13485 and MDR (2017/745) as well as FDA 21 CFR part 820 (QSR) and MDSAP
• Professional experience in regulatory affairs or regulatory compliance in the medical device field. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
• Excellent English and proficient German written and verbal communication skills
• Ability to communicate with all stakeholders
• Independent, structured and pragmatic working style
• Persuasive power

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
• Regular team, and company events
• Internal company fitness program
• Comprehensive training and continuing education opportunities offered by Brainlab SE
• TOP 100 innovator and employer of the future 2022

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

Contact person: Géraldine Ferrer

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