WHAT WE'RE LOOKING FOR
We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our team. This role is crucial in ensuring regulatory compliance for a portfolio of medical devices used with Guerbet's contrast media. You will be responsible for assembling dossiers for global submissions and playing a key role in device change implementation. This is a hybrid position located in Cincinnati, Ohio.
YOUR ROLE
- Prepare international submissions (including CE-mark dossiers) for new products and product changes to facilitate timely approval of market access.
- Communicate directly with international affiliates and distributor partners' regulatory personnel.
- Author dossier content for new device registrations and variations.
- Represent Regulatory on product development teams, developing and executing regulatory plans and providing regulatory impact information for project options.
- Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals, etc.
- Document regulatory activities and approvals to support global market authorizations and ensure files maintain compliance with regulatory requirements.
- Act as a liaison with other departments, e.g., Quality, R&D, supply chain, marketing, vigilance, and medical affairs for support of major initiatives.
- Support internal and external audits/inspections as required (EU notified bodies, FDA, etc.).
- Author and train on regulatory-related standard operating procedures and work instructions as required.
- Compile technical information for regulatory submissions and update internal documentation to track registration approvals.
YOUR BACKGROUND
Education:
BS in Engineering, Science, or related degree; or MS in Regulatory Science.
Experience:
1-2 years' work experience in Medical Device Regulatory Affairs, preferably with FDA and EU-notified bodies submission and international regulatory filings.
Skills/Competencies:
- Good understanding of US, EU, and Canada regulations on medical devices.
- Superior attention to detail.
- Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
- Strong written and verbal communication skills.
- Ability to multitask effectively and work independently with international oversight.
- Experience with medical device product registration and licensing is required.
- Good record-keeping skills.
- Ability to handle multiple tasks/projects.
- Previous experience with Class II/III medical devices preferred.
- Experience drafting regulatory submissions for product approval preferred.