Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.
This is a great step for someone who has progressed to a Manager level and wants to progress into a Director role in the future. If you are looking to take on a challenging role within a rapidly growing division that provides an A+ environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door.
Job Description
- Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)
- Develop Design Dossiers and Technical Files for CE marking purposes
- Develop other international regulatory submissions as required
- Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Review, edit and provide regulatory and quality system approval for project documentation.
- Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.
- Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
- Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
- Develop procedures to ensure regulatory compliance
- Act as an active regulatory representative on project teams
- Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
- Review and provide regulatory authorization for Nonconformance reports (NCR)
- Provide Regulatory Affairs support during internal and external audits.
- Prepare and file facility registration documents
- Conduct external audit activities as requested
- Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
- Develop clinical protocols and clinical study reports
- Prepare and submit medical device reports
- Perform various other duties as assigned
Qualifications
- Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).
- Solid knowledge of US and European regulatory processes, including Class III is required.
- Practical (hands‑on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.
- Experience interacting with U.S. FDA and European Notified Bodies is required.
- Experience presenting at FDA meetings is preferred.
- Sound knowledge and understanding of how IDE‑regulated clinical studies are performed is required.
- Experience in review and approval of promotional review process strongly preferred
- Comprehensive Knowledge of Design Control processes and controls
- Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.
Please send suitable resumes in confidence to JPCuadra @ openscientific.com
Additional Information
All your information will be kept confidential according to EEO guidelines.
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