Website Olympus Corporation of the Americas
To be considered, applicants must apply at our career website: https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=2062&company=olympuscorP
The Specialist European Union Regulatory Affairs will support the regulatory submissions relating to the European Union including updating and maintaining the EU technical files and supporting documentation to ensure they are compliant with the EU Medical Device Regulation (MDR) (2017/745) and supporting the Engineering R&D and other functions on matters relating to EU compliance.
* Maintain and update Gyrus ACMI’s EU Technical Files so they remain compliant with current regulatory and company standards Maintain and update the clinical evaluation documentation to support EU and international regulations.
* Train and advise personnel in Engineering R&D and regulatory functions to ensure awareness of EU requirements.
* Review new standards and regulations as they are issued to determine how they affect Gyrus ACMI products.
* Work with engineering and technical personnel to ensure continued compliance to any revised referenced standards.
* Participate in the development and review of quality system procedures as they relate to EU compliance.
* Participate in regulatory agencies inspections and responses to any findings that may result.
* Support manufacturing engineering quality assurance product development and clinical affairs as required to ensure regulatory compliance.
* Bachelor’s degree preferably in engineering or life sciences or equivalent years of experience.
* Regulatory experience in the Medical Device industry or equivalent degree.
* Minimum of 5 years Regulatory compliance experience in the Medical Device industry with a Bachelor’s degree is required’ Minimum 3 years with a Master’s degree is preferred.
* Minimum of 3 years Regulatory experience in the Medical Device industry preferred.
* Must be able to communicate effectively (verbal and written).
* Must be proficient in Microsoft Office (Word Excel or Access PowerPoint).
* Ability to work in small team environment but also self-starter with ability to work independently.
* Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
* Must be able to meet deadlines and be detail oriented. Good planning and organization skills a must.
* Strong critical thinking and problem solving skills. Strong knowledge of MDR requirements required.
* Documented continuing education in regulatory affairs RAC Certification is a plus.
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