Regulatory Affairs Specialist

Vor 5 Tagen

Munich, Deutschland BAXTER Vollzeit

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

At **Baxter, **we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

For our business division **Baxter Medical **Systems** we are currently looking for a **Regulatory Affairs** **Specialist** - Medical Devices (**M/F/d) **based in Munich, Germany.

Your tasks:

- Provide regulatory input to product lifecycle planning and new product development mainly for surgical lights
- Act as Global Regulatory Lead for surgical lights and work with Country Regulatory colleagues for international registrations of the surgical lights.
- Ensure compliance with regulations (21 CFR 820, MDR), standards (ISO 13485, product specific standards), and the quality manual
- Work closely with product development, clinical, quality and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance)
- Create GSPRC, STEDs and review TD documents, including Clinical Evaluation reports, labeling, advertising, promotion and marketing literature
- Ensure compliance with product post-marketing approval requirements
- Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)
- Support change control activities
- Provide MDR updates/guidance to product development teams

Your profile:

- Completed academic education in a related medical, scientific, engineering services, or regulatory discipline is required
- Minimum of 3 years' experience in creating and managing international regulatory submissions for Medical Devices (Active medical devices of Class I & II preferred)
- Global registration experience for medical devices, limited experience with US 510(k) submission and experience in reviewing technical documents, Project Management skills and experience, ideally with supporting new product developments and launches
- Strong proficiency with Microsoft systems (Excel, PowerPoint, and Word and Teams)
- Strong attention to detail as well as strong questioning and listening skills
- Good planning and organizational skills
- Strong internal customer service orientation with “do whatever it takes” attitude
- Excellent English communication skills are mandatory; good German knowledge is a plus
- Ability to work in cross-functional teams with people from various disciplines and cultures

**What are some of **the **benefits of working at Baxter?**:

- Competitive total compensation package
- Professional development opportunities
- High importance placed on work life balance
- Commitment to growing and developing an inclusive and diverse workforce

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
- Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mi_ssion._
- #IND-DACH_

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review o

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Munich, Bayern, Deutschland HumanOptics Holding AG Vollzeit

    Als innovativer und international ausgerich teter Hersteller von Premium-Implantaten für die Augen chirurgie entwickeln, produ zieren und vertreiben wir Medizin produkte, um dem mensch lichen Auge die bestmögliche Sehkraft zurück zugeben. Zur Verstärkung unseres Teams am Standort Erlangen suchen wir zum nächst möglichen Zeitpunkt in Vollzeit einen...

  • Regulatory Affairs Specialist Medizinische Gase

    Vor 5 Tagen

    Munich, Deutschland Linde GmbH, Gases Division Vollzeit

    Linde GmbH, Gases Division Regulatory Affairs Specialist Medizinische Gase (m/w/d) Unterschleißheim, Deutschland (req12198) **Hier sind Sie in Ihrem Element** - Als Regulatory Affairs Specialist bei QRA stellen Sie sicher, dass erforderliche lokale Zulassungs-Aktivitäten für als Arzneimittel eingestufte medizinische Gasprodukte identifiziert, geplant,...

  • Senior Regulatory Affairs Specialist

    vor 2 Wochen

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Junior Regulatory Affairs Specialist Dach

    vor 2 Wochen

    Munich, Bayern, Deutschland Organon Vollzeit

    **Job Description**:Für die Abteilung Regulatory und Pharmacovigilance in Organon DACH sind wir auf der Suche nach einem/einer**:Junior Regulatory Affairs Specialist DACH (m/w/d)**.In der Rolle berichtest Du direkt an die Direktorin Regulatory Affairs DACH und bist Teil eines zehnköpfigen, länderübergreifenden Teams. Wir bieten Dir mit dieser Rolle den...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Munich, Deutschland LivaNova Vollzeit

    Join us today and make a difference in people's lives! Regulatory Affairs Specialist (M/F/d) Position Summary The Regulatory Affairs Specialist implements and conducts the activities required to obtain and maintain regulatory clearance for the company's medical device products. General Responsibilities - Participating on project teams to provide input to...

  • Specialist Regulatory Affairs

    Vor 5 Tagen

    Munich, Deutschland BAXTER Vollzeit

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Affairs Officer

    vor 3 Wochen

    Munich, Deutschland Servier Vollzeit

    **Datum der Veröffentlichung**:31.07.2023**Stadt**:München**Land/Region**:DE**Vertragstyp**:unbefristet**Stellenanforderungs-ID**:3796Regulatory Affairs Officer - Wir suchen zum nächstmöglichen Termin einen Regulatory Affairs Officer (m/w/d).**Das erwartet Sie**: - Bearbeitung von Zulassungsunterlagen im Rahmen der Arzneimittelentwicklung nach...

  • Regulatory Affairs Cmc

    Vor 7 Tagen

    Munich, Deutschland Stirling Q&R Ltd Vollzeit

    **Position: Regulatory Affairs CMC** **About the Company**: A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence...

  • Team Lead Regulatory Affairs

    Vor 6 Tagen

    Munich, Deutschland TÜV SÜD Product Service GmbH Vollzeit

    Seit 1866 gilt unsere Leidenschaft der Technik und der Sicherheit. Innovationen beeinflussen unser Leben in vielfältiger Weise. Für die Sicherheit von Menschen und der Gesellschaft setzen wir uns jeden Tag aufs Neue ein und schaffen Vertrauen in neue Technologien. Wir sind Teil des Fortschritts. Wir beraten, wir prüfen, wir zertifizieren. Wir handeln aus...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

    **Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.** At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Specialist (M/w/d) Regulatory Affairs

    vor 2 Wochen

    Munich, Deutschland MSD Vollzeit

    Unser Bereich Technische Beratung Veterinärmedizin bietet auf Grundlage seines wissenschaftlichen Hintergrunds technisches Know-how und Beratung sowohl für unsere Kunden als auch für unsere Mitarbeiter im Vertrieb und Marketing. Basierend auf unseren profunden Kenntnissen der Pharmakologie und Tiergesundheit betreiben wir einen wissenschaftlichen...

  • Director Regulatory Affairs Oncology

    vor 2 Monaten

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team, providing expertise on regulatory matters....

  • Associate Regulatory Affairs

    vor 2 Monaten

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: ***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)***: - limited until 31.10.2024 -**: **The position**: Provide support for EU Regulatory Procedural Management for assigned projects including all pre - and post-authorisation activities ensuring a smooth run of regulatory...

  • Junior Regulatory Affairs Specialist Dach

    vor 4 Wochen

    Munich, Deutschland Organon Vollzeit

    **Job Description**: Für die Abteilung Regulatory und Pharmacovigilance in Organon DACH sind wir auf der Suche nach einem/einer**:Junior Regulatory Affairs Specialist DACH (m/w/d)**. In der Rolle berichtest Du direkt an die Direktorin Regulatory Affairs DACH und bist Teil eines zehnköpfigen, länderübergreifenden Teams. Wir bieten Dir mit dieser Rolle...

  • Specialist Quality Assurance

    vor 2 Monaten

    Munich, Deutschland MSD Vollzeit

    **Job Description**: Für unseren Standort in München suchen wir in Vollzeit eine/n **Specialist Quality Assurance & Regulatory Affairs befristet bis Feb 2025**. Unsere Qualitätssicherung gewährleistet, dass alle in unseren Produkten enthaltenen Materialien und Stoffe unter Einhaltung unserer strengen Qualitätsstandards und aller behördlichen Auflagen...

  • Specialist Quality Assurance

    vor 4 Wochen

    Munich, Deutschland MSD Vollzeit

    **Job Description**: Für unseren Standort in München suchen wir in Vollzeit eine/n **Specialist Quality Assurance & Regulatory Affairs befristet bis Feb 2025**. Unsere Qualitätssicherung gewährleistet, dass alle in unseren Produkten enthaltenen Materialien und Stoffe unter Einhaltung unserer strengen Qualitätsstandards und aller behördlichen Auflagen...

  • Working Student

    vor 1 Woche

    Munich, Deutschland Brainlab Vollzeit

    Company Description Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Munich, Bayern, Deutschland 3C – Career Consulting Company GmbH Vollzeit

    Unser Mandant entwickelt, produziert und vertreibt komplexe Medizinprodukte. Im Zuge des starken Wachstums des Unternehmens suchen wir zum nächstmöglichen Zeitpunkt einen Regulatory Affairs Manager (w/m/d) – Medizintechnik APCT1_DE

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Munich, Deutschland ADVITOS GmbH Vollzeit

    Die ADVITOS GmbH ist ein innovatives Medizintechnikunternehmen (70+ Mitarbeiter ) mit Sitz in München, das eine vollkommen neuartige Multiorganunterstützungstherapie von der Idee bis zur Marktreife entwickelt hat. Die weltweit patentierte ADVOS-Therapie (ADVanced Organ Support) verbessert die Überlebensrate von Patienten durch zeitgleiche Unterstützung...

  • Regulatory Affairs Project Manager

    Vor 7 Tagen

    Munich, Deutschland Life Science People Vollzeit

    Calling all Senior Regulatory Affairs Project Managers, this is a unique opportunity to make real change within the regulatory affairs field.I'm working with a client in Bavaria Germany who is a leading consultancy firm within the Regulatory Field. You will be closely working with a wider team to make real change within organisations across the globe within...