Overall responsibility for regulatory submissions of new products to regulatory agencies (US, EU and ROW) and regulatory compliance for existing products. This includes supporting all design control activities, developing regulatory strategy, providing regulatory requirements, supporting the development activities, preparing and submitting new product applications to regulatory agencies and responding to additional information requests.
Roles and Responsibilities
Develop regulatory strategy for submissions of new products and changes to existing products
Support, prepare and coordinate regulatory submissions of new products or changes to existing products.
Prepare and maintain technical files and general safety and performance requirements
Coordinate and communicate activities with external consultants and regulatory bodies
Review DHF documentation to assure compliance with regulatory requirements.
Review and interpret regulatory requirements during product development and communicate to the project team
Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions
Support Risk Management activities
Create, update and maintain standards list
Support manufacturing activities related to the product
Provide requirements for, review and approve product labelling
Support compliant handling
Report to regulatory authorities
Or Yehuda | RA QA
Primary function of the position
Memic is looking for Quality Control to join our team.
The Quality Control ensures that the company's products are in compliance with their specifications, the company's policies and international standards and guidance.
Roles and Responsibilities
Perform variety of inspection activities including visual, dimensional, mechanical and functional inspections
Follow established procedures to ensure compliance with procedures, visual aids, purchased specifications, inspection forms, work orders or engineering drawings;
Perform first article inspections on incoming product;
Initiate nonconforming material reports for product or raw material found to be out of specification. Assisting with investigation and rework;
Ensure compliance of quality records and supporting documents with internal procedures and GDP practices
Review Device History Records and approve products for distribution;
Provides support for technical and quality issues
Maintain production equipment
Participate in internal and external audits
At least 2 years of experience as Quality Control in the Medical Device Industry
Prior work experience in a regulated manufacturing environment (ISO 13485, 21 CFR Part 820)
Basic knowledge and understanding of metrology
Experience in using mechanical and electronic test equipment (i.e: caliper, snap gauge, pin gauge, DVM, micrometer, etc)
Ability to read and interpret documentation such as Standard Operating Procedures (SOP), schematics and technical drawings
Basic computer skills, including basic use of Microsoft Office suite software and NetSuite, or equivalent software
Good English and Hebrew skills
Indications for use: The Hominis® Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms® during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis® Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Hominis® Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy • Total Benign Hysterectomy with Salpingectomy • Total Benign Hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal. Caution: The safety and effectiveness of the Hominis® Surgical System was established only for the representative uses mentioned in the Indications for Use. The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying is ease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon. The prescription-use symbol or “Caution: Federal law restricts this device to sale by or on the order of a physician.” For safety information, including risks, indications, and specific warnings and cautions related to the Hominis System please refer to the Hominis Surgical System Instructions for Use provided with your Hominis Surgical System.