Regulatory Affairs Specialist Kylt®

vor 1 Tag

Hannover, Deutschland SAN Group Biotech Germany GmbH Vollzeit

**Entity **SAN Group Biotech DE**Location **Germany, Höltinghausen**Employment Type **full-time**Career Level **Experienced Professionals***

SAN Vet is the animal health branch of SAN Group. As a globally operating business we contribute to sustainable animal protein production by providing high tech and essential solutions in the areas of biosecurity, veterinary diagnostics, vaccines, in-vitro PCR diagnostica, and pharmaceuticals. Through innovative in-house research and development as well as partnerships with external institutions and universities, we continuously expand in new markets. SAN Vet consists of the brands ANICON®, ANIVAC®, KYLT®, and SANPHAR®.

**These are the tasks we trust in you**:

- International registration of KYLT® in-vitro diagnostic kits
- Preparation of registration documents (reports, dossiers)
- Communication with authorities, industry associations and consultants but also with SAN Vet departments including R+D and sales
- Management of regulatory projects including thorough documentation

**For this position it requires the following**:

- Master degree in natural science (biology, biochemistry, biotechnology) or similar with at least 3 years of working experience in Regulatory Affairs for IVD
- Experience in production of IVD is a plus
- Accurate and precise mode of operation
- Team player with the ability to work with timelines
- Very good communication skills in English and German
- Self-motivated, with a ‘can-do’ attitude

**Become part of our SANtastic culture**:

- First name terms from trainee to owner
- No neckties and open doors
- Small teams to root-in and grow
- High degrees of freedom to create in a positive team atmosphere
- Flexible work hours and home-office
- Catering such as apple box, stew, crispbread, jam & hazelnut cream, drinks...
- givve®Card (tax-free benefit in kind)
- E-bike leasing, childcare and dog area
- Benefits such as team events, state-of-the-art work environment and IT infrastructure, free parking, internal and external development programs

**What else to know?**:

- You are located in **49685 Höltinghausen (DE)** or **home office** with **partial presence in KYLT office **in Höltinghausen
- We appreciate your expertise for **32 hours/week**, part-time, permanent contract
- This position is available immediately however, we are happy to consider your notice period or your desired start date.
- Based on your professional experience and your qualification, we offer you an attractive total compensation package plus attractive benefits.

**STANDORT**:

- Mühlenstraße 13- 49685 Höltinghausen- Germany**KONTAKT**:
Melanie Hoffmann
- +43 2782 83300 166

  • Regulatory Affairs Specialist

    Vor 7 Tagen

    Hannover, Deutschland THUASNE DEUTSCHLAND GmbH Vollzeit

    **Deine Aufgaben** Als Regulatory Affairs Specialist (m/w/d) bei THUASNE DEUTSCHLAND GmbH wirst Du Teil eines dynamischen Teams, das innovative Gesundheitslösungen in den Bereichen Orthopädie, Kompression und Breastcare entwickelt und produziert. Unser Unternehmen steht für langjährige Erfahrung, medizinisches Know-how, herausragende Qualität und ein...

  • Germany HEAD OF REGULATORY AFFAIRS

    vor 1 Woche

    Hannover-Braunschweig-Göttingen-Wolfsburg Region, Deutschland GFIC Geiger Food Ingredients Recruitment & Consult Vollzeit

    GFICHEAD OF REGULATORY AFFAIRS & QUALITY MANAGEMENT (M/W/D)Göttingen, Deutschland (hybrid)Angestellte/rLabor, ForschungFür einen Internationalen Distributor, mit Schwerpunkt Flavours und Food Ingredients suchen wirHEAD OF REGULATORY AFFAIRS & QUALITY MANAGEMENT (M/W/D)Teamführung von 6 Mitarbeitern4 Tage office pro Woche1 Tag home office pro...

  • Head of Quality

    vor 1 Tag

    Hannover, Deutschland Sartorius Vollzeit

    We are currently seeking a Head of Quality & Regulatory Affairs BPS (x|f|m) for the Quality System Compliance BPS division of Sartorius Stedim Biotech GmbH for our site in Goettingen, Aubagne or Royston. In this position you will be a member of the BPS Operations leadership team and will interact closely with the Head of quality LPS as well as the Quality...

  • Specialist Regulatory Reporting

    vor 1 Woche

    Hannover, Deutschland HDI Global Vollzeit

    **Specialist Regulatory Reporting**: **Deine Aufgaben**: - Mitarbeit, Weiterentwicklung und Erstellung der Quartals - und Jahresabschlüsse nach Solvency II - Erstellung und Weiterentwicklung des Reportings an in - und ausländische Aufsichtsbehörden - Übergreifende Abstimmung mit am Abschlussprozess beteiligten Bereichen - Klärung von bilanziellen...

  • Senior Regulatory Specialist

    Vor 5 Tagen

    Hannover, Deutschland Element Solutions Inc Vollzeit

    **Business Overview**: **Job Purpose**: To integrate into the R & D, Marketing and other business units for new and existing products so as to present the regulatory landscape, to communicate upcoming regulations and changes to existing regulations that affect MacDermid Enthone products, and to author Safety Data Sheets for U.S. products and Asia products....

  • Medical Writer

    vor 2 Wochen

    Hannover, Deutschland Med Communications International Vollzeit

    Senior Scientific Communications Specialist English(Medical Writer / Promo Review)Location: Fully Remote Europe Essentials Degree: Advanced degree in Pharmacy (PharmD preferred), advanced healthcare degree, or equivalent clinical experience. Experience: 24 years in scientific content creation within the pharmaceutical industry, medical education, or...

  • Praxistrainer (M/w/d) Für Enercon®

    vor 1 Woche

    Hannover, Deutschland Deutsche Windtechnik GmbH & Co. KG Vollzeit

    Wir sind die Windtastics - 2.200 fantastisch geschulte Menschen voller Tatendrang und mit hohem Wirkungsgrad. Unsere Spezialgebiete sind die Wartung, Reparatur, Verbesserung und Inspektion von Windkraftanlagen. Wir haben für jede Anforderung die passende Lösung und arbeiten zielstrebig daran, die Potenziale von weltweit 7.000 Windparkprojekten voll...

  • Medical Writer

    vor 2 Wochen

    Hannover, Niedersachsen, Deutschland Med Communications International Vollzeit 60.000 € - 120.000 € pro Jahr

    Senior Scientific Communications Specialist English(Medical Writer / Promo Review)Location: Fully Remote Europe Essentials Degree: Advanced degree in Pharmacy (PharmD preferred), advanced healthcare degree, or equivalent clinical experience. Experience: 24 years in scientific content creation within the pharmaceutical industry, medical education, or...

  • Data Architect and Migration Specialist

    vor 2 Wochen

    Hannover, Deutschland TechBiz Global GmbH Vollzeit

    At TechBiz Global, we are providing recruitment service to our TOP clients from our portfolio. We are currently seeking a **Data Architect and Migration Specialist** to join one of our **clients**' teams in **Riyadh**. If you're looking for an exciting opportunity to grow in an innovative environment, this could be the perfect fit for you. **NOTE: This is...

  • Head of Quality Assurance Gmp

    Vor 7 Tagen

    Hannover, Deutschland Biomatch GmbH Vollzeit

    Biomatch ist derzeit für ein führendes Pharmaunternehmen, das sich auf die Entwicklung, Herstellung und Vermarktung hochwertiger Arzneimittel spezialisiert hat, auf der Suche nach einem Head of Quality Assurance GMP (m/w/d). Aufgaben - Leitung des Qualitätssicherungsteams und Sicherstellung der Einhaltung aller relevanten Vorschriften und Richtlinien...