Telephone: 086 8395533
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.
- 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 / firstname.lastname@example.org
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