Senior Regulatory Affairs Specialist

Location: Nieder-Olm, DE- Job Family:
- Country/Region: Germany**_Version EN_**

Tracoe Medical GmbH, with its headquarters and production facility in Nieder-Olm (Rhineland-Palatinate), is one of the leading developers and manufacturers of medical devices and aids for patients with tracheostomies. The focus of the premium product portfolio is on tracheostomy tubes and accessories for patient care in hospitals and in the home care sector. Tracoe Medical has been part of the Atos Medical / Coloplast Group since 2021 and 2022 and employs a total of around 300 people at its Nieder-Olm site. The company can look back on a 60-year history and has already been voted one of the top 100 German SMEs three times.

To strengthen our team, we are looking for the next possible date for a

**Senior Regulatory Affairs Specialist (m/w/d)**

**Preface to the position, scope of activities and position in the company**

In this role, you will present global regulatory affairs for both innovation and lifecycle management projects within our tracheostomy business area. This position offers a broad spectrum of regulatory activities where you will join project teams to advance the regulatory agenda for new products development and the modification of existing products, while driving the transition to the MDR and interacting with our Notified Body. Your primary scope of responsibilities will be the EU and you will closely partner with colleagues worldwide as you build and execute international regulatory strategies.

Taking part in a variety of projects, you will:

- Be involved in developing and launching regulatory strategies
- Write, review and maintain documentation to ensure the regulatory compliance of the technical files supporting our products
- Participate in cross-functional groups dedicated to building knowledge across the organization

**Key activities**:

- Craft global regulatory strategies and provide end-to-end deliverables and submissions/filing for new product introductions, maintenance of regulatory approvals and product changes, with direct responsibility for the EU and through alignment with international counterparts
- Represent function for assigned projects/products by translating regulatory requirements into product requirements, actionable compliance activities and options for regulatory pathways, through transparent and clear communication and focus on collaborative work and solution.
- Assess the global strategy for product claims and associated supporting evidence, and review advertising materials for regulatory compliance
- Assist with import/export and trade compliance activities, good sales practices and requests supporting commercial activities
- Report information into applicable data management systems and maintain internal/external regulatory databases for the assigned products
- Monitor and analyze emerging regulatory intelligence for the assigned regulatory areas
- Participate in development, maintenance and implementation of regulatory procedures, instructions and systems

**Your experience / qualification**:

- Bachelor or Master of Science degree in regulatory science, life science, biomedical engineering, or other relevant scientific or legal field
- Minimum 5+ years’ experience in regulatory affairs - preferably from the MedTech industry or a related field
- In depth knowledge of regulatory legislation, standards, and guidelines for medical devices, in particular MDR, MDSAP, EN ISO 13485, EN ISO 14971
- Fluent in German and English
- Very good MS Office skills

**Your personal skills**:

- Technical writing skills
- Analytical, systematic and solution-oriented way of working
- Strong commitment, initiative and sense of duty
- Holistic thinking and an open-minded attitude
- Experience of working in an international environment

**We offer you**:

- A secure and responsible workplace
- Idea management, freedom to help shape processes and work independently
- A welcoming culture and structured induction
- A friendly working atmosphere and colleagues who treat you as equals
- Part of a successful and dynamic team
- Active promotion of your professional and personal development through internal and external training opportunities
- Active support with health care through an established company health management program (GEMA)
- Flexible working time models and the option of mobile working
- Company events, free parking and much more

Have we piqued your interest?
- ________

**_Version DE_**

Die Tracoe Medical GmbH mit Hauptsitz und Produktionsstätte in Nieder-Olm (Rheinland-Pfalz) gehört zu den führenden Entwicklern und Herstellern von Medizinprodukten und Hilfsmitteln für Patienten mit Luftröhrenschnitt. Der Schwerpunkt des Premiumproduktportfolios liegt auf Tracheostomiekanülen und Zubehör zur Patientenversorgung in der Klinik wie auch im HomeCare-Bereich. Tracoe Medical ist seit 2021 bzw. 2022 ein Unternehmen der Atos Medical / Coloplast Gruppe und beschäftigt insgesamt rund 300