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Vacancy Details

Engineering & Technical

FDA Consultant - International

Contract Type: Permanent
Sector:
Location: International
Date: 17/10/2018
Job Reference: 93778
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

FDA Consultant

Our client, a manufacturing company in The United States of America are currently looking to recruit a FDA Consultant for their site.

Brief JD for Regulatory Specialist:
  • Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
  • Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
  • Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
  • Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
  • Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
  • Assist in development of new product instructions for use/promotional material. Review product labelling for compliance with medical device regulations and Division/Corporate Policies.
  • Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
  • Support due diligence and business integration activities as assigned.
  • 5+ years’ experience developing and executing Regulatory strategies for complex Medical Device development programs is required
  • Risk based decision making experience
  • Cross-functional experience, working with R&D- biology, chemistry or science background is helpful.
  • Negotiate directly with FDA on projects/products at reviewer level.
  • Develop proficiency in US FDA requirements and establish and maintain good working relationships with Regulatory Body personnel.
  • Maintain Regulatory Affairs product files to support compliance with regulatory requirements.

Minimum Requirement:
  • Bachelor’s Degree in science, math or engineering discipline.
  • Minimum of 10 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, technical files and design dossiers).
  • Experience in obtaining PMA approval for DES preferred
  • Class III device experience and in-depth knowledge of US FDA medical device regulations.
  • Expertise on 21 CFR
  • Knowledge of GLP/GCP requirements and excellent negotiation kills and written/oral communication skills.
  • Knowledge of QA system requirements: MDD requirements including Device Experience Reporting.
  • Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices.
  • Working knowledge of Quality System Regulation

Advanced Degree Preferable:
  • R.A.C certification(s).
  • Regulatory Compliance competency (Inspections, Audits, Field Actions, Quality Systems …)
  • International Regulatory competency.
  • Clinical Trial experience.
  • Proficiency in FDA compliance.

For further information on this FDA Consultant role in The United States of America please contact Bimi Felix on 086 8395533 / bimi@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval


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