Regulatory Affairs Specialist Job at Insight Global, Carlsbad, CA

  • Insight Global
  • Carlsbad, CA

Job Description

Insight Global is looking for a Regulatory Affairs Specialist that will be responsible for the regulatory functions including support of labeling requirements, serving as regulatory representative on selected project teams. You will also support compilation and submission of regulatory submissions for biologics products primarily but may assist with other product portfolio as needed.

Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

Day to Day Responsibilities:

  • Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups
  • Represent regulatory on various projects supporting compliance for biologics (Human Tissue Based and Medical Devices) products
  • Provide regulatory guidance to design team for device labeling, promotional materials, and sales training material
  • Prepare and submit regulatory filings for new products or changes to existing products, including management of interactions with regulatory authorities and ensuring that all activities are accurately and timely documented
  • Support compilation and maintenance of design dossiers and technical flies
  • Work with other cross functional members in support of international registrations, renewals and tenders
  • Maintain current knowledge of new regulations, policies, guidance documents, etc. issued by relevant regulatory authorities, which may impact the company xhyhwjd
  • Perform other duties as assigned

Must Have Requirements:

  • Bachelors Degree
  • 3-5 years of experience in with the biologics or medical device industry in the regulatory affairs field.
  • Experience preparing and submitting documents sent over to government agencies
  • Experience preparing and executing regulatory presentations
  • Experience with blood, human, cell, tissue based products

Job Tags

Similar Jobs

CenterWell Home Health

Home Health Baylor Registered Nurse Job at CenterWell Home Health

 ...Pay Per Visit/Unit Rate $49.00 - $69.00 Additional Information TB Statement: This role is considered patient facing and is part of Humana's Tuberculosis (TB) screening program. If selected for this role, you will be required to be screened for TB. Driving Statement: This... 

University of Wisconsin

Assistant Professor of Philosophy Job at University of Wisconsin

 ...Faculty Employment Type: Regular Job Profile: Assistant Professor Job Summary: The highly ranked Department of Philosophy, in collaboration with the Integrated Liberal Studies (ILS) program, is seeking excellent junior candidates for a tenure-track... 

Eurofins USA PSS Insourcing Solutions

GMP Analytical Chemist Job at Eurofins USA PSS Insourcing Solutions

 ...osmolality, concentration, break-loose extrusion force, etc.) Prepare standards and samples for analysis Maintain, calibrate, and operate instrumentation in the QC laboratory Document work as required for GMP compliance Execute work in accordance with standard... 

Simon Eye Associates

Medical Receptionist Job at Simon Eye Associates

 ...person our patients see and an important part of creating a welcoming, organized, and positive...  ...service to every patient. This is a part-time position that will generally work 3 days...  ...team Availability to work at least one evening per week and two Saturdays per month to... 

Slalom

AI/ML Architect - Consultant / Senior Consultant (US - WEST) Job at Slalom

 ...experience implementing models or machine learning algorithms into production.* 2-4 years of professional Managed or IT Professional consulting experience. * Strong consultative and communication skills, and the ability to convey complex technical concepts to diverse...