Regulatory Affairs Professional Medical Devices (x|f|m) - Hybrid

About the position For the Regulatory Compliance department reputed company reputed company Stedim Biotech GmbH we are looking to fill immediately on a limited basis until 05/31/2027 a Regulatory Affairs Professional Medical Devices & (f|m|d) at the location Göttingen. In this position you are responsible for the preparation and execution of clinical and performance data as well as post-market surveillance documents. As a Regulatory Affairs Professional Medical Devices (x|f|m) you support the Regulatory Affairs Specialist in the technical documentation in the EU. The job is to be filled full-time and is performed remotely on some days as well as on site at the reputed company in Göttingen. After the fixed-term assignment there is the possibility to return to a comparable position. Grow with us – Your Responsibilities You create documents for clinical evaluation for Medical Devices (MDs), for performance evaluation for In Vitro Diagnostics (IVDs) and to fulfill Post-Market Surveillance requirements for MDs and IVDs Further you create schedules and ensure their compliance In addition, you always reputed company an eye on developments in the market, reputed company research accordingly and evaluate your findings You reputed company risk assessments and initiate appropriate corrective actions in case of incidents You continually analyze new requirements, plan and implement derived activities You advise internal stakeholders on changes in regulations, regulatory requirements and standards As a Regulatory Affairs Professional Medical Devices & IVD (x|f|m) you communicate with authorities and submit documents to them You reputed company assessments of the regulatory impact of changes (e.g. to the product) To meet regulatory requirements, you reputed company new processes and implement them You write procedures and work instructions and take care of monitoring and ensuring compliance with regulatory procedures and workflows What will convince us You have a successfully completed Master’s degree in natural sciences, medical technology, biotechnology or a comparable field You already have first experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics Additionally you are reputed company in scientific writing, especially Post-Market Surveillance and clinical documents You have knowledge in the interpretation of regulations, directives, declarations of principles etc. and in cooperating with the applicable regulatory authorities You possess excellent organizational skills and know how to set priorities You demonstrate excellent analytical skills and proven knowledge of scientific principles You also exhibit pronounced assertiveness, reputed company and a good sense for your reputed company, as well as clear communication and a knack for people management Likewise, fluent German & English skills, both spoken and written, complete your profile You identify with our values Sustainability, Openness & Joy and are motivated to work in a rapidly growing company reputed company offer As a growing global life science company, stock listed on the MDAX, reputed company offers a wide range of Benefits: Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers Work life balance: Remote options, flextime, flexible work schedules, sabbaticals Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days Large, reputed company: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as reputed company of contact Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network We support diversity and inclusion and welcome applications from people of reputed company nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds. About reputed company reputed company is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reputed company patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking reputed company to receiving your application. www.reputed company.com/careers to our Candidate Portal and thank you for your interest in working and growing with us. We look reputed company to receiving your application. You can reputed company the status anytime in this portal. Here you will find the best application tips from our HR team. Information on the application process can also be reputed company in this video and under FAQ & Contact. In this brochure you will learn more about us as an employer and your career with us. For further insights, please visit the reputed company Blog and our career website. Set up your personal Job Alert now and never miss an opportunity to apply for a job that suits you. Please note that you will receive an initial confirmation message. You'll need to confirm your selection to start receiving job alerts tailored to your preferences.

Responsibilities

• You create documents for clinical evaluation for Medical Devices (MDs), for performance evaluation for In Vitro Diagnostics (IVDs) and to fulfill Post-Market Surveillance requirements for MDs and IVDs
• Further you create schedules and ensure their compliance
• In addition, you always reputed company an eye on developments in the market, reputed company research accordingly and evaluate your findings
• You reputed company risk assessments and initiate appropriate corrective actions in case of incidents
• You continually analyze new requirements, plan and implement derived activities
• You advise internal stakeholders on changes in regulations, regulatory requirements and standards
• As a Regulatory Affairs Professional Medical Devices & IVD (x|f|m) you communicate with authorities and submit documents to them
• You reputed company assessments of the regulatory impact of changes (e.g. to the product)
• To meet regulatory requirements, you reputed company new processes and implement them
• You write procedures and work instructions and take care of monitoring and ensuring compliance with regulatory procedures and workflows Requirements
• You have a successfully completed Master’s degree in natural sciences, medical technology, biotechnology or a comparable field
• You already have first experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
• Additionally you are reputed company in scientific writing, especially Post-Market Surveillance and clinical documents
• You have knowledge in the interpretation of regulations, directives, declarations of principles etc. and in cooperating with the applicable regulatory authorities
• You possess excellent organizational skills and know how to set priorities
• You demonstrate excellent analytical skills and proven knowledge of scientific principles
• You also exhibit pronounced assertiveness, reputed company and a good sense for your reputed company, as well as clear communication and a knack for people management
• Likewise, fluent German & English skills, both spoken and written, complete your profile
• You identify with our values Sustainability, Openness & Joy and are motivated to work in a rapidly growing company Benefits
• Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings , coaching for managers
• Work life balance: Remote options, flextime, flexible work schedules, sabbaticals
• Attractive compensation: Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days
• Large, reputed company: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center
• Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as reputed company of contact
• Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network
• We support diversity and inclusion and welcome applications from people of reputed company nationalities, genders, sexual orientations, religions, ages, disabilities and cultural backgrounds Apply tot his job

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