A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.
Requirements: 3 to 5 years of Class II medical device quality and/or regulatory experience is required.
Bachelors degree preferably in a scientific discipline such as Science, or Engineering or
equivalent experience. Regulatory Affairs Certification (RAC) advantage
Strong regulatory/quality writing skills
Ability to apply business and Regulatory Affairs ethical standards
Excellent analytical and critical thinking skills
Strong verbal and written communication skills, including a proven ability to translate
technical
documentation into effective quality documentation and regulatory submissions
Strong understanding of FDA and EU regulatory process
Experience in Risk Management per ISO 14971 and QMS per ISO 13485
Good interpersonal skills and able to work well with cross-functional teams
Able to work independently with minimal instructions/supervision
Capable of multi-tasking and rapidly adapting to changing priorities.
This position is open to all candidates.
