B.Sc. in a scientific, technical discipline, or engineering
Project Management skills
At least 6 years of hands-on experience with medical device clinical submissions
Familiarity with IDE/IND, ITA/CTA, EU CTAs submissions
Strong verbal and written communication abilities
Experience working with cross-functional global teams
Responsibilities
Prepare and maintain clinical regulatory submissions for INSIGHTEC products
Review clinical documents to ensure regulatory compliance and clarity
Act as the US Agent for INSIGHTEC
Manage processes supporting Regulatory, Clinical, and Post-marketing activities
Oversee annual renewals of licenses and registrations
Evaluate customer complaints for regulatory reportability
Support audits and ensure compliance with new regulations
Benefits
Opportunity to work with innovative medical technology
Engagement with cross-functional and global teams
Involvement in the regulatory aspect of advanced medical devices
Professional development opportunities related to project management and regulatory compliance
Flexibility to influence and implement compliance processes in a dynamic environment
Full Job Description
Description
What you will be doing:
Preparation and maintenance of clinical regulatory submissions of INSIGHTEC products in relevant markets.
Review clinical documents for regulatory appropriateness; Provide review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Serve as US Agent for Insightec
Manage cross-functional processes to support Regulatory, Clinical and Post marketing activities related to INSIGHTEC products:
o Management of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
o Review of customer complaints to determine reportability according to regulatory requirements.
o Provide ongoing regulatory support and assessments to Promotional materials
o Manage company's knowledge of new standards, guidance, regulations and other applicable standards to ensure ongoing regulatory compliance
o Provide support for all external/internal audits at HQ and globally
Work closely with various other INSIGHTEC teams (e.g. R&D, Clinical, Quality, Marketing) both locally and globally.
Working according to Insightec quality policy, procedures & standards, and privacy & safety rules.
Qualifications:
B.Sc. degree in scientific / technical discipline / engineering
Project Management skills
A minimum of 6 years of Hands-on experience with medical devices clinical submissions, including IDE/IND, ITA/CTA, EU CTAs
Strong verbal and written communication skills
Ability to work with cross-functional global teams
