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.

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
  • 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

Mortenson

Power Electrical Helper - Texas Job at Mortenson

 ...Electrical Helper SUMMARY Mortenson is currently seeking an Electrical Helper that...  ...level electrician. Responsibilities include installing, repairing, and maintaining energy...  ...various hand tools Safely use hand and power tools after proper training (drills, crimpers... 

DBI Consultants

Estimator I Job at DBI Consultants

 ...Estimator Position at DBI Construction Consultants At DBI Construction Consultants, we are construction experts who specialize in evaluating...  ...is required to view a computer terminal, use a keyboard, read printed documents, make detailed visual inspections, perceive color,... 

Zen Educate

Behavior Technician - School Setting Job at Zen Educate

 ...plans, de-escalating challenging situations, and applying therapeutic or behavioral strategies are all highly transferable to school settings. \n These paraprofessional roles in SPED Classrooms are a natural next step if you want to continue making a real impact, with... 

C.T. Male Associates

Renewable Energy Site Development Project Manager Job at C.T. Male Associates

C.T. Male Associates seeks a dedicated Renewable Energy Site Development Manager to oversee the development of green energy projects from inception to completion. This role involves project management, design oversight, and coordination between multiple stakeholders to... 

LifeSource, Inc.

Setting Interviews - PMHNP or Psych PA opportunity - Outpatient Office Job at LifeSource, Inc.

Job Description Job Description NEW - Hiring Now for a Part-Time PMHNP for our thriving Wilmington outpatient office...Established Outpatient Practice (18 yo and up)***Ideally searching for a candidate that would be open to working with us 20 hours/week to start...