Regulatory Affairs Assistant

Advanced Medical Solutions; Nürnberg; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A global leader in advanced wound care is seeking a Regulatory Affairs Assistant in Nuremberg. The role involves preparing regulatory documentation, maintaining compliance for surgical products, and contributing to new product development. Candidates should have a science-based degree and experience in medical devices is preferred. Strong communication and organizational skills are essential. This position offers an opportunity to impact healthcare outcomes worldwide.

Qualifikationen

• Experience in medical devices is preferred.
• Awareness of regulatory requirements; direct experience is highly desirable.
• Ideally, experience with market approval processes in Europe and the USA.

Aufgaben

• Preparing and submitting regulatory-compliant documentation.
• Maintaining registrations, licenses, certifications, and submissions.
• Conducting regulatory reviews and approvals of compliance-related documents.

Kenntnisse

Proficiency in written and spoken English

Strong organisational skills

Analytical thinking

Ability to influence and challenge constructively

Ausbildung

Science-based degree or equivalent

Tools

Microsoft Office

Jobbeschreibung

We’re Hiring! | Regulatory Affairs Assistant - Nuremberg

www.admedsol.com

Who are Advanced Medical Solutions (AMS)?

AMS is a global leader in advanced wound care and surgical solutions. We develop and manufacture cutting-edge tissue-healing technologies that improve outcomes for patients and deliver value for healthcare providers. With a portfolio of innovative products like LiquiBand, RESORBA, ActivHeal, and Seal-G, we serve healthcare systems worldwide.

Since 2019, AMS has acquired seven pioneering companies across Europe and Israel, strengthening our capabilities in internal sealants, surgical biomaterials, and advanced wound care.

With 1,500+ employees, manufacturing in 8 countries, and R&D hubs in 5, AMS continues to grow rapidly. Learn more about our journey at www.admedsol.com.

Job Details

We’re looking for a dedicated Regulatory Affairs professional to support the development of new Biosurgical products and the preparation of regulatory submissions for Europe, the USA, and international markets, ensuring compliance with applicable regulatory requirements. This role also supports the ongoing compliance of already marketed products within the Biosurgicals category.

What will this role involve?

• Preparing and submitting high-quality, regulatory-compliant documentation for all product classes across Europe, the USA, and other global markets to secure timely approvals
• Maintaining current registrations, licenses, certifications, and submissions to ensure alignment with evolving medical device regulations globally
• Keeping Regulatory Technical Documentation up to date
• Serving as a core team member on new product development projects and major line extensions, ensuring all Regulatory Affairs activities are integrated into the project plan
• Supporting the creation of Regulatory Strategy documents for new products
• Conducting regulatory reviews and approvals of compliance-related documents such as design controls, labelling, marketing materials, change controls, and risk management files
• Managing assessments and submissions related to device changes, manufacturing processes, and updates to the quality management system
• Supporting and participating in quality system audits
• Monitoring industry developments in regulatory affairs
• Continuously improving internal processes for generating and maintaining regulatory documentation
• Supporting post-market surveillance activities, including compiling and reporting data such as vigilance reports, customer feedback, post-market clinical trends, and proactive market intelligence

What we're looking for

• A science-based degree (or equivalent); experience in medical devices is preferred
• Proficiency in written and spoken English
• Awareness of regulatory requirements; direct experience is highly desirable
• Ideally, experience with market approval processes in both Europe and the USA
• Excellent written and verbal communication skills, including with internal teams, customers, and Regulatory Authorities
• Strong organisational skills – able to work efficiently, respond quickly, and collaborate effectively in a team setting
• Ability to perform under pressure and meet timelines and compliance standards
• Strong analytical thinking
• The ability to influence and challenge constructively to drive improvement
• Proficient in Microsoft Office and other tools used to prepare and manage regulatory documentation, files, and logs

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.