требуется Regulatory Affairs and Quality Manager in medical software company in Petah Tikva
Looking for Regulatory Affairs and Quality Manager in medical software company in Petah Tikva.
Job Description:
The Company develops software solutions for treatment and management of Diabetes,
works closely with medical excellence centers around the globe and KOL in the field of diabetes,
developing products that will change the lives of millions of people with diabetes and their caregivers.
Position description:
• Develop and execute the company's regulatory strategy for its product pipeline.
• Develop and maintain submissions to regulatory agencies required to allow The company's products
to be sold in all regions and markets. (FDA, CE, Health Canada)
• Develop and maintain the The company's Quality Management System and supporting procedures capable
of meeting ISO 13485, ISO 63204, ISO 14971, as well as FDA (QSR), EU - Medical Device Regulation,
and Health Canada (CAN-ISO 13485) requirements
• Manage auditing activities from the different regulatory agencies including Notified Bodies, FDA,
Health Canada and other agencies.
• Monitor all of the software developing and testing activities (including their relevant documentations)
to ensure adherence and conformity with The company's Quality Management System.
• Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations.
• Maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications
and submissions to regulatory agencies
• Develop quality system documentation (such as procedures and work instructions) to address new and updated standards and guidance’s, as required.
• Assist as required during clinical trials in accordance with rules mandated by regulatory agencies.
• Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
• Provide responses to regulatory agencies regarding product information or issues.
• Train staff in regulatory policies or procedures.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
as well as reporting to the regulatory authorities as needed.
Requirements:
• Formal post-secondary degree/diploma in regulatory affairs related to a Medical Device - required.
• Regulatory Affairs and Quality Assurance certifications - asset
• Strong understanding and hands-on experience (5+ years) with medical device software regulation and QA according to ISO 13485,
ISO 62304, ISO 27000, MDR, GDPR, FDA (QSR) is required
• Proven track record of developing and managing quality management system that fits to medical device software development
organization - required
• Proven track record of drafting and submission of pre-submissions, 510(k) applications to the FDA as well as submission
of Technical File for review of Notified Body - required
• Experience with digital systems to ensure compliance of software development and commercial organization with quality
management system - asset.
Please, send your cv to anna@specialjob.co.il
http://www.specialjob.co.il/en/hot_jobs/
Thanks,
Anna.
Job Description:
The Company develops software solutions for treatment and management of Diabetes,
works closely with medical excellence centers around the globe and KOL in the field of diabetes,
developing products that will change the lives of millions of people with diabetes and their caregivers.
Position description:
• Develop and execute the company's regulatory strategy for its product pipeline.
• Develop and maintain submissions to regulatory agencies required to allow The company's products
to be sold in all regions and markets. (FDA, CE, Health Canada)
• Develop and maintain the The company's Quality Management System and supporting procedures capable
of meeting ISO 13485, ISO 63204, ISO 14971, as well as FDA (QSR), EU - Medical Device Regulation,
and Health Canada (CAN-ISO 13485) requirements
• Manage auditing activities from the different regulatory agencies including Notified Bodies, FDA,
Health Canada and other agencies.
• Monitor all of the software developing and testing activities (including their relevant documentations)
to ensure adherence and conformity with The company's Quality Management System.
• Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations.
• Maintain knowledge about applicable standards, directives and guidance’s necessary to facilitate notifications
and submissions to regulatory agencies
• Develop quality system documentation (such as procedures and work instructions) to address new and updated standards and guidance’s, as required.
• Assist as required during clinical trials in accordance with rules mandated by regulatory agencies.
• Assist as required to develop project documentation (for example, risk plans) as required for inclusion in regulatory submissions
• Provide responses to regulatory agencies regarding product information or issues.
• Train staff in regulatory policies or procedures.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
as well as reporting to the regulatory authorities as needed.
Requirements:
• Formal post-secondary degree/diploma in regulatory affairs related to a Medical Device - required.
• Regulatory Affairs and Quality Assurance certifications - asset
• Strong understanding and hands-on experience (5+ years) with medical device software regulation and QA according to ISO 13485,
ISO 62304, ISO 27000, MDR, GDPR, FDA (QSR) is required
• Proven track record of developing and managing quality management system that fits to medical device software development
organization - required
• Proven track record of drafting and submission of pre-submissions, 510(k) applications to the FDA as well as submission
of Technical File for review of Notified Body - required
• Experience with digital systems to ensure compliance of software development and commercial organization with quality
management system - asset.
Please, send your cv to anna@specialjob.co.il
http://www.specialjob.co.il/en/hot_jobs/
Thanks,
Anna.