QM Consultant - Regulatory Affairs

Brainlab; Waldkirch; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical technology company in Waldkirch is seeking a QM Consultant in Regulatory Affairs. This role involves establishing regulatory strategies, collaborating on technical documentation, and ensuring compliance with medical device regulations. The ideal candidate has a relevant degree and professional experience in regulatory affairs, along with excellent communication skills in English and German. Join a supportive team with meaningful work and opportunities for training and growth.

Leistungen

30 vacation days plus holidays

Flexible working hours

Internal fitness program

Qualifikationen

• Experience in regulatory affairs in the medical device field.
• Able to evaluate design changes during development.
• Knowledge of EN ISO 13485 and MDR regulations.

Aufgaben

• Collaborate on technical documentation for CE marking.
• Establish global regulatory strategies for medical devices.
• Compile regulatory submissions to authorities.

Kenntnisse

Knowledge of medical device regulations

Excellent written and verbal communication in English

Proficient in German

Ability to communicate with stakeholders

Persuasive power

Ausbildung

Degree in medical engineering or life sciences

Jobbeschreibung

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