Director, Regulatory Affairs- Medical Device
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team!
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Associate Director, Regulatory Affairs to join our device team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- 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 FDA, including, pre-IND and other consultations with FDA, new IND's, updates to IND's, and original/supplemental NDA filings;
- Provide regulatory review of study protocols, investigator's brochures, labeling, and integrated summary documents;
- Collaborate with EU regulatory to develop global approval strategies;
- Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements; and
- Maintain up-to-date knowledge of regulatory requirements.
Qualifications
- Bachelor's Degree in a related field;
- A minimum of 10 years of Regulatory Affairs experience in the device industry;
- Experience working in a small, global company is preferred;
- Strong computer skills, project management skills, and a high attention to detail; and
- Strong communication skills (both written and oral).
- This position may require supervision of junior level staff
Travel:
Up to 15% travel
WHY MEDPACE?
At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.
WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
Estimated Salary: $20 to $28 per hour based on qualifications.
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