Jobs at Gerresheimer

Head Regulatory Affairs (m/f/d)

Solothurnerstrasse 235, Switzerland | Olten | Full-time

Stellenbeschreibung

As Head of Regulatory Affairs you will manage a team of currently 3 internal employees and 2 external contractors. The group is responsible for global submissions and requirements related to Class I, II and III medical devices in the EU and the United States. Combination products will be developed and released with an pharmaceutical partner as legal manufacturer with contribution for submission from Gerresheimer Olten. You provide leadership to cross-functional teams during new product development. You have the functional responsibility for development projects from the feasibility phase to the timely approval of products in international markets. Therefore you work in a close cooperation with other departments like Development, Product Management, Medical and Quality.

Furthermore your team develop regulatory strategies for new and modified medical devices in different markets. You manage technical guidance and training to  the RA team and also cross-functional teams including training on procedures, FDA, MDR guidance documents, and international regulation. Your team take care of various regulatory documents e.g. such as Intended Use, Classification, Applicable Standards List, Essential Principles throughout the whole life cycle of the product. In relation to the needed documentation you need to review protocols and reports to support regulatory compliance. You and your team is in charge to write  submissions for new devices and device change notifications as required. You will also contribute to the further development of regulatory processes in the quality management system (QMS).

Depending on the regulations you may need to approve manufacturing changes for compliance with applicable regulations (Change Control) or device labeling for compliance with US, EU and International submissions and applicable regulations.

You will take responsibility for complex submission projects and ensure internal and external communication with regulatory partners of customers and suppliers, authorities and notified bodies. In general you also need to evaluate, document and communicate changes to authorities, customers and notified bodies and also interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as during audits to mitigate any potential risks

Qualifikationen

You hold a degree in science or engineering (or comparable education) combined with a minimum of 4 years of experience and knowledge in the regulatory affairs for medical devices (drug-delivery devices, active and network-enabled medical devices advantageous).

Your experience in the registration of products in the USA, and EU (other markets desirable) and your excellent technical writing experience within a medical device environment will help make you very successful. Your strong verbal and written communication skills in English and German will keep up the momentum of the communication at multiple levels in the organization, with stakeholders and authorities.

You have very good leadership skills and also skills as a teamplayer. You are able to empower and motivate people t reach the goals and finding pro-active solutions.

Zusätzliche Informationen

We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.

Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.

Your contact person - For further information please contact Mr. René Ziegler, Senior Recruiting Specialist, +41 62 209 71 00

Benefits

Corporate Benefits

Benefit from special conditions with various brands in fashion, technology, leisure and many more.

Food & drinks

We offer you free beverages and snacks.

Healthcare & pension

Your health and well-being is important to us. We offer fitness trainings, company pension plans and a group insurance.

Learning & development

According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities.

Mobile working

Mobile working and home office arrangements make our work routine more flexible.

Working environment

Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).

Note: Benefits might vary depending on the position.

Über Gerresheimer

Gerresheimer ist der globale Partner für Pharmazie, Biotech, Gesundheit und Kosmetik mit einem sehr breiten Produktspektrum für Arzneimittel- und Kosmetikverpackungen sowie Drug Delivery Devices. Das Unternehmen ist ein innovativer Lösungsanbieter vom Konzept bis zur Lieferung des Endprodukts. Gerresheimer erreicht seine ehrgeizigen Ziele durch ein hohes Maß an Innovationskraft, industrieller Kompetenz sowie Konzentration auf Qualität und Kundenfokus. Bei der Entwicklung innovativer und nachhaltiger Lösungen setzt Gerresheimer auf ein umfassendes internationales Netzwerk mit zahlreichen Innovations- und Produktionszentren in Europa, Amerika und Asien. Gerresheimer produziert weltweit mit rund 11.000 Mitarbeitern nah beim Kunden und erwirtschaftet im Geschäftsjahr 2022 einen Jahresumsatz von 1,817 Mrd. Euro. Gerresheimer spielt mit seinen Produkten und Lösungen eine wesentliche Rolle für die Gesundheit und das Wohlbefinden von Menschen.

Equal rights

Wir verpflichten uns zu einem integrativen Einstellungsverfahren und zur Chancengleichheit für alle unsere Bewerber.  Alle Bewerber werden unabhängig von ethnischer und nationaler Herkunft, Hautfarbe, Glaube, Religion, Alter, Geschlecht, Geschlechtsidentität, sexuelle Orientierung, Familienstand, Behinderung, genetische Informationen, Staatsbürgerschaft oder einen anderen gesetzlich geschützten Status berücksichtigt. Menschen mit Schwerbehinderung werden bevorzugt eingestellt.

Interessiert? Dann bewerben Sie sich noch heute!