Regulatory Affairs Specialist - TX-59057087

Advanced Medical Solutions

We're Hiring! | Regulatory Affairs Specialist - Nuremberg / Remote UK or France (FTC 18m)

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 .

Job Details

A specialist in Regulatory Affairs to support Integration project activities within the Biosurgical category. This is a fixed term role for 18 months, core team is based in Germany. The candidate would ideally be based in Germany and able to visit our German manufacturing sites. Role could also be remote from UK or France.

What will this role involve?

• Being a core team member of project team.
• Developing right regulatory strategy and inputting into project timelines ensuring all regulatory deliverables are considered.
• Preparing Class III technical documentation for change submissions to authorities and partners in EU and rest of world.

What we're looking for?

• Significant experience in reaching regulatory success of change control projects for CE marking according to MDD and MDR requirements.
• Ability to work within a project based role with pre-determined timelines.
• Excellent communicator and collaborator within cross functional teams
• Desirable experience of providing regulatory support to collagen manufacturing
• Proficient in both German and English language desirable. Minimum English.
• Comprehensive understanding and practical experience in compliance to the Medical Device Regulations 2017/745

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.