Global Regulatory Affairs Manager

18 hours ago


Istanbul, Istanbul, Turkey Solventum Full time

Solventum is a forward-thinking organization that empowers its employees to drive innovation and excellence. Our company culture values diversity, creativity, and continuous improvement, providing a dynamic environment where talented professionals can grow and thrive.

We're seeking a highly skilled and experienced professional to join our team as a Senior Specialist Regulatory Affairs (m/f/*). This role offers an exciting opportunity to leverage your expertise in regulatory affairs to shape the future of healthcare.

The Impact You'll Make in this Role
  • Acting as liaison between design center regulatory affairs, regulatory consultants and distributors to enable registrations in select EMEA countries
  • Managing compliance projects, developing and implementing regulatory strategies and submissions for medical devices in select EMEA countries
  • Ensuring compliance with country regulatory requirements for market access and vigilance of medical devices
  • Implementing regulatory strategies during product development/ introduction and /or product modification, ensuring all changes reflected in country registrations including correct labelling
  • Preparing and maintaining regulatory documents for registration submissions
  • Communicating to authorities, notified bodies, consultants and distributors etc.
  • Preparing country-specific documentation requests for registrations, bid & tenders & reimbursement 
  • Monitoring emerging regulations affecting medical devices in select EMEA  countries.
Your Skills and Expertise 

To achieve success in this role, you'll need (at a minimum) the following qualifications:

  • Scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
  • Proven experience in regulatory affairs in the medical device or pharmaceutical industry.
  • Ideal background includes knowledge of medical device regulations and standards such as EN ISO 13485, EU MDR 2017/745, GMP, etc.
  • Able to work collaboratively in cross-functional and cross-cultural teams
  • Excellent communication and problem-solving skills
  • Able to interact with regulatory agencies and notified bodies
  • Able to utilize databases and regulatory submission request tools
  • Fluent English language skills, both written and verbal
  • Bonus points for additional EMEA languages
Work Location: Hybrid in Istanbul or Remote within TurkeyMust be Legally Authorized to Work in Country of Employment Without Sponsorship for Employment Visa Status

  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum is a global leader in pioneering game-changing innovations at the intersection of health, material and data science. We're committed to improving lives by creating breakthrough solutions for our customers' toughest challenges.We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum is a leading innovator in the healthcare industry, dedicated to creating breakthrough solutions for our customers' toughest challenges. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with country regulatory requirements for market access and vigilance of medical devices.The successful candidate will...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum is a leading innovator in the medical device industry, committed to creating breakthrough solutions for our customers' toughest challenges. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulations and standards for medical devices in select EMEA countries.The successful candidate will have...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum is a pioneer in game-changing innovations at the intersection of health, material, and data science, creating breakthrough solutions for our customers' toughest challenges. As a Senior Regulatory Affairs Specialist, you will be part of a team that ensures every solution created meets the highest standards of quality and safety.The ideal candidate...


  • Istanbul, Istanbul, Turkey Solventum Full time

    At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum is a global leader in the creation of innovative medical devices, dedicated to improving lives through better, smarter, and safer healthcare solutions. As a Senior Regulatory Affairs Specialist, you will join a team that shares your passion for excellence and commitment to quality.The ideal candidate will have experience in regulatory affairs in...


  • Istanbul, Istanbul, Turkey Solventum Full time

    Solventum's vision is to revolutionize healthcare by harnessing the power of innovation, collaboration, and expertise. Our team is driven by a passion to create groundbreaking solutions that transform patients' lives.We strive to foster a culture of openness, respect, and continuous learning, where talented individuals can grow and thrive. If you're...


  • Istanbul, Istanbul, Turkey ZF Friedrichshafen AG Full time

    Job DescriptionWe are seeking a skilled Procurement Manager for NPM to join our team in Gebze. The successful candidate will have a proven track record in non-production material purchasing and excellent analytical and negotiation skills.Key AccountabilitiesDevelop and implement effective procurement strategies to meet business objectives.Build and maintain...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    international finance corporationIFC a member of the World Bank Group is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities. Our mission is to leverage the power of the private sector to end extreme...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    international finance corporationIFC a member of the World Bank Group is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities. Our mission is to leverage the power of the private sector to end extreme...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    international finance corporationIFC a member of the World Bank Group is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities. Our mission is to leverage the power of the private sector to end extreme...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    international finance corporationIFC a member of the World Bank Group is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities. Our mission is to leverage the power of the private sector to end extreme...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    International Finance Corporation Job DescriptionCompany OverviewThe International Finance Corporation (IFC), a member of the World Bank Group, is a leading global development institution focused on the private sector in emerging markets. With operations in over 100 countries, we leverage our capital, expertise, and influence to create markets and...


  • Istanbul, Istanbul, Turkey ZF Friedrichshafen AG Full time

    Procurement Specialist Job DescriptionWe are seeking a detail-oriented and organized Procurement Specialist to join our team in Gebze. The successful candidate will have a strong understanding of procurement principles and excellent analytical skills.AccountabilitiesAssist the Procurement Manager in developing and implementing procurement strategies.Manage...


  • Istanbul, Istanbul, Turkey ZF Friedrichshafen AG Full time

    ZF is looking for a talented Product Development Manager TR to join our team in Istanbul.Key Responsibilities:Create and implement regional product range development plans for respective portfolios.Responsible for end-to-end sales & margin in the region for respective portfolios.Key Requirements include:Minimum 3 years experience in product management,...


  • Istanbul, Istanbul, Turkey ZF Friedrichshafen AG Full time

    Purchasing Manager Job SummaryZF Friedrichshafen AG is seeking a highly motivated and experienced Purchasing Manager to join our team in Gebze. The successful candidate will have a proven track record in non-production material purchasing and excellent leadership skills.ResponsibilitiesLead the procurement team to achieve business objectives and deliver...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    Company OverviewIFC, a member of the World Bank Group, is the largest global development institution focused on the private sector in emerging markets. We work in over 100 countries using our capital, expertise, and influence to create markets and opportunities.Job DescriptionThe IFC Regional FIG Department is seeking two interns as part of our Global...


  • Istanbul, Istanbul, Turkey ZF Friedrichshafen AG Full time

    We are expanding our Sales & Market team across Istanbul and seek a highly motivated IMEA Regional Product Owner Transmission to join us.Responsibilities include:Define and execute regional portfolio strategy as part of regional category book workstream.Support regional front-line sales team to ensure seamless go-to-market strategy of existing portfolio and...


  • Istanbul, Istanbul, Turkey international finance corporation Full time

    Company OverviewInternational Finance Corporation is the largest global development institution focused on the private sector in emerging markets. Our mission is to leverage the power of the private sector to end extreme poverty and boost shared prosperity on a livable planet.Job DescriptionThe IFC Global Internship Program offers highly motivated...