Staff Regulatory Affairs Specialist

Salary depends on experience
Posted on 11/22/17
5 - 7 years experience
Medical Equipment
Salary depends on experience
Posted on 11/22/17

Job Description

The Staff Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices in EU and otherinternational markets.

This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business.

The Staff Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices in EU and otherinternational markets.

This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business.

Job responsibilities:

  • Understands and interprets EU in vitro diagnostic device (IVD) regulatory requirements.
  • Provides guidance on requirements to product development teams.
  • Performs gap analysis of existing Technical Files against EU IVDR, and represents RA in cross-functional teams tasked to fill the gaps.
  • Develops strategies for submissions to Notified body.
  • Provides risk assessments and regulatory options.
  • Completes and updates Technical File necessary for new product approval and product continuance.
  • Prepares and/or compiles information required by international regulatory associates to register or license products outside the EU.
  • Interacts and negotiates with Notified body. 
  • Coordinates the preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all such requests. 
  • Participates in the development and review of Performance evaluationreport. 
  • Reviews Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions. 
  • Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies. 
  • Provides regulatory opinions on pre-market regulatory requirements, export, and labeling requirements.

Minimum Qualifications:

  • Bachelor's degreerequired, strongly preferred in the biological sciences, chemistry or related science.
  • Minimum 5 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Tech file preparation and approval experience a plus.
  • Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret EU in vitro diagnostic device (IVD) regulatory requirements.
  • Current knowledge of EU medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards. 
  • Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. 
  • Ability to prioritize, multi task, and organize work; project management experience desirable.

Job ID R-23079

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.