B.Sc. degree in a scientific, technical discipline, or engineering
Project management skills
Minimum of 6 years hands-on experience with clinical submissions for medical devices (IDE/IND, ITA/CTA, EU CTAs)
Strong verbal and written communication skills
Ability to collaborate with cross-functional global teams
Responsibilities
Prepare and maintain clinical regulatory submissions for INSIGHTEC products
Review clinical documents for regulatory accuracy and clarity
Serve as the US Agent for INSIGHTEC
Manage cross-functional processes supporting Regulatory, Clinical, and Post marketing activities
Handle annual renewals of regulatory licenses and registrations
Assess customer complaints for regulatory reportability
Ensure ongoing knowledge of new standards and regulations for compliance
Benefits
Support for external and internal audits at HQ and globally
Opportunity to work closely with R&D, Clinical, Quality, and Marketing teams
Engagement in a quality-driven work environment following safety rules
Access to a network of experienced professionals and industry experts
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
