Senior Regulatory Affairs Specialist

22 godzin temu


Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat
Join Solventum as a Senior Regulatory Affairs Specialist

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Solventum. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with current national, European, and international regulatory and standard requirements for manufacturing, market access, and vigilance of medical devices.

Key Responsibilities:
  • Manage compliance projects and develop and implement international regulatory strategies for medical devices.
  • Ensure compliance with current national, European, and international regulatory and standard requirements for manufacturing, market access, and vigilance of medical devices.
  • Drive regulatory strategies during product development or product modification.
  • Create, develop, and maintain regulatory documents for European and international product submissions.
  • Support and further develop the quality management system according to EN ISO 13485, EU MDR 2017/745, and MDSAP.
  • Communicate with authorities, notified bodies, etc.
Requirements:
  • Engineering/scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
  • Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry.
  • Ideal knowledge of medical device regulations EN ISO 13485, EU MDR 2017/745, MDSAP, US QSR, GMP, etc.
  • Fluent English language skills, both written and verbal.
What We Offer:

Solventum offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunity employer and value diversity at our company. We are committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.



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