At ProClinical, we are seeking an office-based Director, Regulatory Affair, based in Cincinnati, OH. The successful individual will work with a team to accomplish tasks and projects that are instrumental to the company's success.
- Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval.
- Interact with FDA, including preparation of PMA/IDE/510K submissions.
- Manage relationship with international regulatory agencies.
- Plan, review, approve required documents from various departments for filing of required information to regulatory bodies.
- Provide regulatory review of study protocols, investigator's brochures, labeling, and integrated summary documents.
- Collaborate with EU regulatory team to develop global approval strategies.
- Provide regulatory advice and guidance to project teams.
- Maintain up-to-date knowledge of regulatory requirements.
Skills And Qualifications
- BA in related field.
- 10+ years of Regulatory Affairs experience in the device industry.
- Strong written, verbal, and interpersonal communication skills.
- Experience in supervision of junior-level staff preferred.
- Up to 15% travel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Reid Schalet at (+1) 6463672908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.