Senior / Lead Regulatory Affairs Specialist (M/F/d)

vor 4 Monaten

Freiberg, Deutschland Stryker Corporation Vollzeit

As the **Senior Regulatory Affairs Specialist (M/F/d),** your role involves collaborating on Stryker's **Spine** **portfolio for Global Regulatory release. This entails contributing to the development and updating of regulatory strategy based on regulatory changes. You will play a key role in supporting the product lifecycle through obsolescence, assessing changes made to the device post-launch to determine the regulatory impact on the current clearance.

Additionally, you will actively participate in cross-functional teams, formulate global regulatory strategies, author regulatory submissions, engage with regulatory agencies/notified bodies. This position is integral to supporting the Spine product portfolio, Spine navigation solution utilizing advanced software aimed at enhancing patient outcomes.

**What will you do**
- As the Senior Regulatory Affairs Specialist, you will assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- You will provide regulatory information and guidance for product development/ enhancement and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- You will develop regulatory strategy and update strategy based upon regulatory and product changes
- You will evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
- You will perform regulatory impact assessment of post-market changes with no supervision.
- You will identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
- You will determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

**What will you need**
- You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.
- You have gained a minimum of 2 years’ experience in medical technology or another regulated sector in the area of quality or regulatory affairs. Medical Device regulatory affairs experience is preferred.
- You already have experienced working with ISO 13485 and 21 CFR 820 compliance
- Your English and German language(preferred) skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.

**Additional information**

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title.

**Your contact**:
**About Stryker

  • Senior Regulatory Affairs Specialist

    vor 4 Monaten

    Freiberg, Deutschland Stryker Corporation Vollzeit

    As the **Senior Regulatory Affairs Specialist (M/F/d),** your role involves collaborating on Stryker's **Spine** **portfolio for Global Regulatory release. This entails contributing to the development and updating of regulatory strategy based on regulatory changes. You will play a key role in supporting the product lifecycle through obsolescence, assessing...

  • Senior / Staff Capa Specialist (M/F/d)

    vor 4 Monaten

    Freiberg, Deutschland Stryker Corporation Vollzeit

    As a** Senior / Staff CAPA Specialist (M/F/d)** at Stryker, you'll be integral to our Quality Management System (QMS) team, ensuring that our NC/CAPA processes and procedures are not only compliant but also optimized for effectiveness and efficiency in addressing quality issues. At Stryker, we're at the forefront of medical technology, dedicated to...

  • Lead Account Executive

    vor 1 Monat

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    Position: Senior Account ManagerCompany: teamtechnik Maschinen und Anlagen GmbHAbout Us: teamtechnik has been a pioneer in automation since 1976, focusing on innovative assembly and testing systems.We are part of the Dürr Group, a leader in efficient production technology.Our workforce consists of over 1,100 dedicated professionals committed to delivering...

  • Lead Client Relationship Manager

    vor 1 Monat

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    Position: Senior Account ManagerCompany: teamtechnik Maschinen und Anlagen GmbHAbout Us: teamtechnik has been a pioneer in automation since 1976, focusing on innovative assembly and testing systems.We are part of the Dürr Group, a leader in efficient production technology.Our global workforce of over 1,100 professionals is dedicated to advancing high-tech...

  • Commercial Operations Specialist

    vor 3 Wochen

    Freiberg, Sachsen, Deutschland ECOBAT Resources Freiberg GmbH Vollzeit

    Job Summary We are seeking a highly skilled and experienced Commercial Operations Specialist to join our team at ECOBAT Resources Freiberg GmbH. About Us ECOBAT Resources Freiberg GmbH is a leading international company specializing in the environmentally friendly extraction of lead and PP-compounds from recycled materials, as well as the safe disposal of...

  • Commercial Operations Specialist

    vor 4 Wochen

    Freiberg, Sachsen, Deutschland ECOBAT Resources Freiberg GmbH Vollzeit

    Job Summary We are seeking a highly skilled and experienced Commercial Operations Specialist to join our team at ECOBAT Resources Freiberg GmbH. About Us ECOBAT Resources Freiberg GmbH is a leading international company specializing in the environmentally friendly extraction of lead and PP-compounds from recycled materials, as well as the safe disposal of...

  • Internal Sales Specialist

    vor 4 Monaten

    Freiberg, Deutschland Peter Stupp Design Mode GmbH Vollzeit

    RICH & ROYAL ist eine erfolgreiche, trendorientierte und hochwertige Premium Modern Womenswear Marke „Made in Europe“. Dahinter steht die Peter Stupp Design Mode GmbH als inhabergeführtes Familienunternehmen mit einer flachen Hierarchie und schlanken Strukturen, sowie jungen und dynamischen Teams. Als Internal Sales Specialist (m/w/d) bist du...

  • Internal Sales Specialist

    vor 4 Monaten

    Freiberg, Deutschland Peter Stupp Design Mode GmbH Vollzeit

    RICH & ROYAL ist eine erfolgreiche, trendorientierte und hochwertige Premium Modern Womenswear Marke „Made in Europe“. Dahinter steht die Peter Stupp Design Mode GmbH als inhabergeführtes Familienunternehmen mit einer flachen Hierarchie und schlanken Strukturen, sowie jungen und dynamischen Teams. Als Internal Sales Specialist (m/w/d) bist du...

  • Internal Sales Specialist

    vor 2 Monaten

    Freiberg, Deutschland Peter Stupp Design Mode GmbH Vollzeit

    RICH & ROYAL ist eine erfolgreiche, trendorientierte und hochwertige Premium Modern Womenswear Marke „Made in Europe“. Dahinter steht die Peter Stupp Design Mode GmbH als inhabergeführtes Familienunternehmen mit einer flachen Hierarchie und schlanken Strukturen, sowie jungen und dynamischen Teams.Als Internal Sales Specialist (m/w/d) bist du...

  • Specialist Geoinformatics

    vor 3 Monaten

    Freiberg, Deutschland Arcadis Vollzeit

    **Stellenbezeichnung**: Specialist Geoinformatics (w/m/d) Referenznummer: 22441 **Standorte**: Freiberg (Sachsen), Dresden, Leipzig, Halle und Berlin Arcadis ist das führende globale Planungs - und Beratungsunternehmen für die natürliche und vom Menschen gestaltete Umwelt. Wir sind 36.000 Menschen in über 70 Ländern, die sich für die Verbesserung der...

  • Projektleiter/Lead-Ingenieur (w/m/d) Automation

    vor 1 Monat

    Freiberg, Deutschland SpiraTec AG Vollzeit

    Projektleiter/Lead-Ingenieur (w/m/d) Automation bei SpiraTec AG | softgarden View job here Projektleiter/Lead-Ingenieur (w/m/d) Automation Vollzeit ...

  • Senior Buchhalter

    vor 1 Monat

    Freiberg, Deutschland Peter Stupp Design Mode GmbH Vollzeit

    RICH & ROYAL ist eine erfolgreiche, trendorientierte und hochwertige Premium Modern Womenswear Marke „Made in Europe“. Dahinter steht die Peter Stupp Design Mode GmbH als inhabergeführtes Familienunternehmen in zweiter Generation, das seit 1986 Fashion mit Trendgespür und einem nachhaltigen Bewusstsein kreiert. Du bist routiniert im Kontakt mit...

  • Cleaning Specialist

    vor 4 Wochen

    Freiberg, Sachsen, Deutschland Stölting Service Group Vollzeit

    We are seeking a reliable and detail-oriented Cleaning Specialist (m/w/d) to join our team at Stölting Facility & Service Südwest GmbH in Freiberg am Neckar.About the Role:Perform regular cleaning tasks to maintain a high level of cleanliness and hygiene in our facilities.Work in a part-time capacity, with a fixed schedule from Monday to...

  • Cleaning Specialist

    vor 3 Wochen

    Freiberg, Sachsen, Deutschland Stölting Service Group Vollzeit

    We are seeking a reliable and detail-oriented Cleaning Specialist (m/w/d) to join our team at Stölting Facility & Service Südwest GmbH in Freiberg am Neckar.About the Role:Perform regular cleaning tasks to maintain a high level of cleanliness and hygiene in our facilities.Work in a part-time capacity, with a fixed schedule from Monday to...

  • Lead Automation Software Engineer

    vor 3 Wochen

    Freiberg, Sachsen, Deutschland emagine Consulting Vollzeit

    emagine Consulting is seeking a Lead Automation Software Engineer (m/w/d) to enhance our team.Key Responsibilities:Automation Software Development: Develop and implement automation software for advanced medical technology systems.System Implementation: Oversee the installation of systems at client locations, both nationally and internationally.System...

  • Lead Automation Software Engineer

    vor 2 Monaten

    Freiberg, Sachsen, Deutschland emagine Consulting Vollzeit

    emagine Consulting is seeking a Lead Automation Software Engineer (m/w/d) to enhance our team.Key Responsibilities:Automation Software Development: Develop and implement automation software for advanced medical technology systems.System Implementation: Oversee the installation of systems at client locations, both nationally and internationally.System...

  • Lead Client Relationship Manager

    vor 1 Monat

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    Position: Senior Account ManagerCompany: teamtechnik Maschinen und Anlagen GmbHAbout Us:Established in 1976, we have been at the forefront of automation.We specialize in innovative assembly and testing systems as part of the Dürr Group.Our global workforce exceeds 1,100 dedicated professionals focused on enhancing production technology for advanced...

  • Automation Specialist

    vor 2 Wochen

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    We live automation at teamtechnik Maschinen und Anlagen GmbH, a leading company in the field of automation technology. As a specialist in the Dürr Group, we have been delivering high-efficiency production technology for high-tech products since 1976. Our team of over 1,100 employees worldwide is dedicated to realizing innovative solutions for the...

  • Automation Specialist

    vor 2 Wochen

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    We live automation at teamtechnik Maschinen und Anlagen GmbH, a leading company in the field of automation technology. As a specialist in the Dürr Group, we have been delivering high-efficiency production technology for high-tech products since 1976. Our team of over 1,100 employees worldwide is dedicated to realizing innovative solutions for the...

  • Lead Client Relationship Manager

    vor 1 Monat

    Freiberg, Sachsen, Deutschland teamtechnik Maschinen und Anlagen GmbH Vollzeit

    Position: Senior Account ManagerCompany: teamtechnik Maschinen und Anlagen GmbHAbout Us: teamtechnik has been a pioneer in automation since 1976, focusing on innovative assembly and testing systems as part of the Dürr Group.Our Workforce: With a dedicated team of over 1,100 professionals worldwide, we are committed to enhancing production technology for...