Responsibilities

Conduct gap analyses of regulatory documents and QMS documentation, and implement necessary updates.
Keep regulatory documentation, including laws, standards, regulations, and guidance documents, current to ensure continuous compliance of QMS and products.
Identify and execute regulatory pathways for successful market access.
Promote improvements in QMS processes.
Administer and maintain QMS documentation.
Advise other departments on regulatory and quality-related activities.
Plan and conduct employee training sessions.
Maintain and continuously improve the ISMS in line with ISO/IEC 27001.
Ensure smooth integration of ISMS processes with other QMS processes.

Requirements

Minimum of four years of experience in Regulatory Affairs or Quality Department for medical devices, preferably medical device software.
At least two years of experience managing QM systems compliant with ISO 13485.
In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820, and relevant sections of the FD&C Act.
Experience in creating and adapting SOPs and Working Instructions with departments such as R&D and Product Management.
Experience in Regulatory Affairs for the USA market is beneficial.
Experience in medical device vigilance is a plus.
Knowledge of ISO 14971, EN 62304, and EN 62366 is advantageous.
Good understanding of ISO 27001.
Certification as an internal auditor for ISO 13485 and ISO 27001 is a major plus.
Ability to work independently with a strong sense of responsibility.
Proactive in identifying improvement opportunities and finding solutions for stakeholders.
Detail-oriented with excellent time management and organizational skills.
Effective communication and active listening skills in international and interdisciplinary teams.
Proficiency in English (written and spoken); German proficiency is beneficial.

Benefits

Senior QA/RA ISMS Manager