3 days ago

Senior Regulatory Affairs Officer

Adecco Human Resources AG

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Your challenges
· Ensuring that a company's products comply with the regulations requirements;
· Participate in product development projects to provide supporting regulatory documentation;
· Collecting and evaluating analytical data that has been researched by colleagues (development and performance studies, clinical field trials) to ensure regulatory requirements are met;
· Writing clear, accessible product labels and patient information leaflets;
· Developing and writing clear arguments and explanations for new product licences and licence renewals;
· Monitoring and setting timelines for licence variations and renewal approvals;
· Liaising with, and making presentations to, regulatory authorities;
· Negotiating with regulatory authorities for marketing authorisation;
· Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standards, the 98/79/EC IVD Directive, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

Senior Regulatory Affairs Officer

Your challenges · Ensuring that a company's products comply with the regulations requirements · Participate in product development projects to provide supporting regulatory documentation · Collecting and evaluating analytical data that has been researched by colleagues development and performance studies clinical field trials to ensure regulatory requirements are met · Writing clear accessible product labels and patient information leaflets · Developing and writing clear arguments and explanations for new product licences and licence renewals · Monitoring and setting timelines for licence variations and renewal approvals · Liaising with and making presentations to regulatory authorities · Negotiating with regulatory authorities for marketing authorisation · Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice cGMP ISO13485 standards the 98/79/EC IVD Directive FDA Regulations Health Canada Medical Device Regulation Part 1 Good Clinical Practice GCP and approved Health and Safety Policies. Senior Regulatory Affairs Officer Your challenges · Ensuring that a company's products comply with the regulations requirements · Participate in product development projects to provide supporting regulatory documentation · Collecting and evaluating analytical data that has been researched by colleagues development and performance studies clinical field trials to ensure regulatory requirements are met · Writing clear accessible product labels and patient information leaflets · Developing and writing clear arguments and explanations for new product licences and licence renewals · Monitoring and setting timelines for licence variations and renewal approvals · Liaising with and making presentations to regulatory authorities · Negotiating with regulatory authorities for marketing authorisation · Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice cGMP ISO13485 standards the 98/79/EC IVD Directive FDA Regulations Health Canada Medical Device Regulation Part 1 Good Clinical Practice GCP and approved Health and Safety Policies. Your skills · Master degree or equivalent diploma in science Master Degree in Biology Biochemistry Immunology Virology or related field. · A minimum of 5 years of experience in regulatory within the IVD Industry prior experience in Infectious Diseases Screening Assay a must. · Previous experience in launching new product to market significant experience of Design Control. · Significant specialist knowledge of regulation as it applies to medical devices IVDs Drugs or Biologics as well as related Industry standards. · Fluent in English About Spring Professional Spring Professional is a subsidiary of The Adecco Group the world's leading provider of human resources solutions. We specialise in the professional recruitment and placement of qualified professionals and middle and senior management specialists in the fields of science IT engineering health care and key corporate positions. Find out what we can do for you. Apply for this job or for one of over 500 other vacancies at SpringProfessional.ch Your contact Are you interested Please apply directly online. The reference of this job ad is JN -072017-46002.

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