Regulatory Specialist - Medical Devices - Elmhurst

Michael Page

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Summary

One of our best clients is growing and looking to add a Regulatory Specialist to their Quality team. They are located in the Elmhurst area and are a Class II Medical Device manufacturer and a HME distributor. They have been in business for over 15 years and have a national presence and pride themselves on high quality affordable products.

Client Details

One of our best clients is growing and looking to add a Regulatory Specialist to their Quality team. They are located in the Elmhurst area and are a Class II Medical Device manufacturer and a HME distributor. They have been in business for over 15 years and have a national presence and pride themselves on high quality affordable products.

Description

This position will be responsible for leading the Regulatory Affairs and Quality assurance initiatives and registrations/listings for all products. The RA Specialist will also be responsible for managing and working with the Quality Assurance to facilitate a compliant Quality Management Systems and implementation of Quality and Regulatory initiatives.

  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.

Profile

  • Bachelors degree preferred
  • 2-7 years' experience in Regulatory Affairs
  • Excellent attention to detail and follow through required
  • Knowledge of FDA (cGMP), ISO 13485:2016, and CMDCAS/MDSAP
  • Proficiency in Microsoft Office and related applications
  • Commitment to excellence, high standards and acute attention to detail
  • Excellent written and oral communication skills
  • Ability to build relationships across diverse workgroups
  • Strong organizational, problem-solving, and analytical skills
  • Ability to manage priorities and workflow
  • Demonstrated ability to plan and organize projects
  • Good judgement with the ability to make timely and sound decisions

Job Offer

  • Competitive base salary, between $75,000 - $85,000
  • Yearly bonus, based on department and personal performance
  • 4% 401k match, eligible day 1
  • Benefits including, medical, dental, life, disability
  • 15 PTO Days + 9 holidays
  • Ability to work from home for 2 days/week

Job Requirements

 

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