Regulatory Affairs Associate

Advanced Medical Solutions; Deutschland; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Une entreprise leader dans le développement de dispositifs médicaux recherche un Regulatory Affairs Associate pour garantir la conformité des produits sur le marché mondial. Le candidat idéal aura un diplôme scientifique, au moins 2 ans d'expérience en affaires réglementaires, et sera bilingue anglais/allemand. Le rôle implique une interaction constante avec diverses parties prenantes et une responsabilité clé dans les enregistrements réglementaires internationaux.

Qualifikationen

• Minimum 2 ans d'expérience en affaires réglementaires.
• Expérience avec dispositifs médicaux et expositions MDR 2017/745 préférées.
• Compétences en anglais et allemand à l'écrit et à l'oral requises.

Aufgaben

• Compiler et soumettre les soumissions réglementaires.
• Assurer les enregistrements actuels et les certifications réglementaires.
• Participer aux audits par les autorités.

Kenntnisse

Communication

IT Skills

Influencing

Ausbildung

Science based degree or equivalent

Jobbeschreibung

Vacancy Name
Regulatory Affairs Associate

About AMS

Who are Advanced Medical Solutions?

When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we're not joking. But we're much more than that...

With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We're highly dependent on the creativity of our employees for our future growth and success. Our motto 'Care, Fair, Dare' summarises our culture, and defines the principles of how we operate as one team to achieve success.

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.

Job Details

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.

Key responsibilities

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

Employment Basis
Full Time

Location Country
Germany

Location City
Nuremberg

Applications Close Date
30 Sep 2025