Senior Regulatory Affairs Specialist

vor 1 Woche

Aachen, Deutschland Johnson & Johnson Vollzeit

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

**Responsibilities**:
The **Senior Regulatory Affairs Specialist (M/F/d)** will be responsible for product submissions to Regulatory authorities in Asia, primarily to the Chinese NMPA. This includes Abiomed internal work, e.g., participation in project teams, training of other departments and advice to the management. The Senior Regulatory Affairs Specialist will also act as a key liaison with the local consultants and partners as needed.
- Be passionate about regulatory affairs leadership in support of the production and distribution of state-of-the-art medical devices
- Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
- Understand the impact of global registrations and product commercialization
- Develop and execute regulatory submission strategies for existing and new products throughout the product lifecycle that are consistent with business unit goals and objectives for the area of responsibility
- Drive regulatory planning for the assigned market (focus: China) and ensure alignment with business and functional goals and priorities
- Present to and negotiate with consultants and, where applicable, agency reviewers as needed
- Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
- Provide input to the product development and engineering teams to ensure that International RA requirements are understood, and submission and marketing risks mitigated as part of the product development and the change process
- Follow changes of the regulatory landscape in assigned countries (through consultants, where applicable), identify impact to the company and develop solutions to maintain regulatory compliance

**Qualifications**:
**QUALIFICATIONS**:

- Degree in engineering or related science required, advanced degree preferred
- Several years of regulatory affairs experience; with a cardiovascular device company preferred
- Solid experience and proven track record in successful submissions to regulatory agencies in Asia, ideally NMPA
- Exhibited strong project management and leadership skills
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
- Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
- Ability to act independently to determine methods and procedures
- Fluency in English and German is a plus

**We offer**:

- Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives"
- Comprehensive induction program with structured onboarding plan throughout the orientation phase
- Company pension allowance of up to 1,500 euros per year and capital-forming benefits
- Benefit packages for occupational disability insurance and company group accident insurance
- Full cost coverage for a job ticket in the Aachen or Berlin area
- Various health programs and a leasing option for a job bike

ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.

  • Senior Regulatory Affairs Specialist

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Abiomed Vollzeit

    Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany,...

  • Senior Regulatory Affairs Specialist

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Abiomed Vollzeit

    Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives.We have a single guiding mission: "Patients First." With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,000 employees form one of the fastest growing medical technology companies in the world....

  • Senior Regulatory Affairs Specialist

    vor 2 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany,...

  • Senior Regulatory Affairs Specialist

    vor 4 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany,...

  • Senior Regulatory Affairs Specialist

    vor 4 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany,...

  • Senior Regulatory Affairs Specialist

    vor 3 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany,...

  • Regulatory Affairs Specialist

    vor 2 Monaten

    Aachen, Deutschland BioTalent Vollzeit

    Role: Regulatory Affairs Specialist Location: AachenAbout Us: This company is a a leading innovator in Medical Device specifically within the area of cardiology specifically manufacturing class II Devices Key Responsibilities:Ensure compliance with regulatory requirements.Prepare and submit regulatory technical documentation such as participation in the...

  • Senior Regulatory Affairs Specialist

    vor 4 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the...

  • Senior Regulatory Affairs Specialist

    vor 2 Wochen

    Aachen, Deutschland Johnson & Johnson Vollzeit

    Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Aachen, Deutschland Medical Magnesium GmbH Vollzeit

    Wir suchen Dich als Regulatory Affairs Specialist zum nächstmöglichen Zeitpunkt! medical magnesium entwickelt metallische bioabsorbierbare Implantate für die orthopädische und unfallchirurgische operative Therapie. Die Implantate sind mechanisch belastbar und werden nach der Frakturheilung vom Körper physiologisch abgebaut. Eine zweite Operation zur...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical technology companies in the...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Aachen, Deutschland Abiomed Vollzeit

    Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical technology companies in the...

  • Regulatory Affairs Specialist

    vor 2 Monaten

    Aachen, Deutschland Zentis GmbH & Co. KG Vollzeit

    Seit über 125 Jahren steht Zentis für erstklassige Konfitüre, Süßwaren und Fruchtzubereitungen. Fundament unseres Erfolges sind eine hohe Innovationskraft und eine kompromisslose Qualitätspolitik. Wir verbinden das handwerkliche Können eines traditionsreichen Familienunternehmens mit dem hohen Anspruch, immer das Beste aus Früchten zu machen. Deshalb...

  • Associate Director Regulatory Affairs

    vor 1 Woche

    Aachen, Deutschland PAION Pharma GmbH Vollzeit

    **Your tasks**: The Associate Director Regulatory Affairs is responsible for establishing and implementing the regulatory CMC strategy for PAION in cooperation with other relevant functions (locally and globally). This person ensures the update of the CMC dossier in a timely manner by authoring and reviewing relevant M1, M2 and M3 documentation. In addition,...

  • Associate Director Regulatory Affairs

    vor 1 Monat

    Aachen, Deutschland PAION Pharma GmbH Vollzeit

    Your tasksThe Associate Director Regulatory Affairs is responsible for establishing and implementing the regulatory CMC strategy for PAION in cooperation with other relevant functions (locally and globally). This person ensures the update of the CMC dossier in a timely manner by authoring and reviewing relevant M1, M2 and M3 documentation. In addition, the...

  • Associate Director Regulatory Affairs

    vor 3 Wochen

    Aachen, Deutschland PAION Pharma GmbH Vollzeit

    Your tasksThe Associate Director Regulatory Affairs is responsible for establishing and implementing the regulatory CMC strategy for PAION in cooperation with other relevant functions (locally and globally). This person ensures the update of the CMC dossier in a timely manner by authoring and reviewing relevant M1, M2 and M3 documentation. In addition, the...

  • Abteilungsleiter (M/w/d) Regulatory Affairs

    vor 2 Wochen

    Aachen, Deutschland VYGON Vollzeit

    Wir suchen zum nächstmöglichen Zeitpunkt im Bereich Qualitätsmanagement & Produktentwicklung einen** Abteilungsleiter (m/w/d) Regulatory Affairs.** **Ihre Aufgaben**: - Sie übernehmen die Abteilungsleitung Regulatory Affairs und koordinieren die Zulassung der Medizinprodukte von VYGON Aachen unter MDR - Sie führen die Mitarbeiter*innen der Abteilung...

  • Regulatory Affairs

    vor 3 Wochen

    Aachen, Deutschland GNT International Vollzeit

    **In Voll - oder Teilzeit** **Employment**: Full time 16 February 2023 **Let’s color the world!** Wir sind GNT, ein innovatives, familiengeführtes Unternehmen mit buntem Charakter! Mit unserer Marke EXBERRY® sind wir führender Hersteller auf dem Gebiet der Färbenden Lebensmittel. Unsere Farben sind 100 % natürlich und aus Obst, Gemüse und Pflanzen...

  • Regulatory Affairs Spezialist

    vor 2 Monaten

    Aachen, Deutschland PERM4 | Permanent Recruiting GmbH Vollzeit

    **Regulatory Affairs Spezialist (w/m/d)**: - Ref.Nr.: PERM4-040614 - Branche: Medizintechnik - Ort: Aachen **Für unseren Kunden in Festanstellung zum nächstmöglichen Zeitpunkt**: **Ihre Aufgaben**: - Verantwortlich für die Vorbereitung, Erstellung und Aktualisierung von technischen Dokumentationen für nationale und internationale Produktzulassungen -...

  • Regulatory Affairs Spezialist

    vor 2 Stunden

    Aachen, Deutschland PERM4 | Permanent Recruiting GmbH Vollzeit

    **Regulatory Affairs Spezialist (w/m/d)**: - Ref.Nr.: PERM4-040614 - Branche: Medizintechnik - Ort: Aachen **Für unseren Kunden in Festanstellung zum nächstmöglichen Zeitpunkt**: **Ihre Aufgaben**: - Verantwortlich für die Vorbereitung, Erstellung und Aktualisierung von technischen Dokumentationen für nationale und internationale Produktzulassungen -...