Cantel Medical Regulatory Affairs Specialist in United Kingdom
The Regulatory Affairs Specialist supports and improves the Cantel EU regulatory compliance position by completing regulatory affairs tasks to help achieve RA departmental and overall business objectives. Responsible and accountable for regulatory affairs and compliance activities for all company product lines in both domestic UK and international markets with primary focus with on the Cantel UK business and supporting focus on German, France and Benelux regions. Assist in the determination of regulatory pathways and requirements for new and revised products and project teams throughout the company. Plan, develop, prepare and submit regulatory submissions to appropriate agencies both domestic UK and international markets with primary focus with on the Cantel UK business and supporting focus on German, France and Benelux regions. Facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations. Coordinate vigilance and post-market surveillance activities and serve as the formal designated safety officer for Cantel UK.
Execute regulatory affairs and compliance activities for company product lines in both domestic UK and international markets with primary focus on the Cantel UK business and supporting focus on Germany, France and Benelux regions. Ensure company products and operations comply with applicable international standard requirements including ISO 13485 and EU MDD/MDR requirements.
Assist in development and execution of regulatory strategies. Review and determine regulatory implications of product, labeling and/or other documentation or design changes.
Participate on project teams to provide regulatory support and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
Manage UK RA submissions activity in accordance with business objectives.
Coordinate vigilance and post-market surveillance activities for Cantel UK
Collaborate with management in establishing departmental strategies and procedures in support of business objectives.
Provide support and on-site guidance as needed for regulatory compliance inspections/audits of Cantel UK facilities as needed.
Participate in Cantel UK and wider global project activities with respect to Brexit.
BS Degree in a scientific, engineering or technical discipline with 2-3 years experience in regulatory affairs, preferably in medical devices, or equivalent.
Masters degree in regulatory affairs, scientific, engineering or technical discipline and professional certification is preferred.
Developed knowledge of international regulations in the areas of the medical devices/technology, ISO 13485 and EU MDD/MDR.
Experience in microbiology, medical hygiene, sterilization/disinfection and device reprocessing preferred.
Proof of strong written and verbal communication skills, especially when dealing with governmental agencies English language capability. Ability to explain and resolve differences in regulations.
Experience in planning and preparing international regulatory submissions is required. General computer knowledge and experience using Microsoft Office software.
External Company URL: https://www.cantelmedical.eu/