🚨 We’re Hiring! | Regulatory Affairs Associate - Nuremberg
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
The regulatory affairs associate will play a critical role in ensure the compliance of device manufactured by the Advanced Medical Solutions Group in all global markets. The role is a key role within the business, interfacing with customers, notified bodies, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis.
What will this role involve?
Key Accountabilities
* Compile and submit regulatory submissions for approval in applicable markets
* Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices framework in the countries registered
* Supporting and advising other functions within the business for information and registration requests
* Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on product registrations
* Support customer market registration activities, within the terms of existing contractual obligations
* Conduct Regulatory Change Assessments
* Participate in and support audits/reviews by regulatory authorities and customers in regards to the International Registrations system including preparation, facilitation and response
* Monitor relevant industry-wide International Registration activities
* Continuous improvement and development of the international registrations process
* Support internal customer projects including artwork changes and new territory expansions and/or launches
* Promote and demonstrate Care, Fair and Dare values in the workplace
* Promote health and safety policies in the workplace
What we're looking for?
* Science based degree or equivalent
* At least 2+ years’ experience in Regulatory Affairs
* Medical device experience and exposure to MDR 2017/745 preferred
* Proficiency in written and spoken English required
* Proficiency in written and spoken German required
* Ideally has experience in key market approval requirements globally
* Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities
* Competent IT skill in preparing files
* The ability to influence and challenge others in a constructive way so as to deliver improvements
* The ability to manage workload and time effectively
* Due to the nature of the role deadline delivery is critical, whilst meeting enforced regulatory timelines
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.