My client in Ohio is actively hiring Medical Device experts with experience working on Class III, Cardiovascular products to lead their Regulatory Affairs team in a very visible role. Become part of a dynamic organization offering excellent salary, benefits, and room for professional growth!
The Director, Global Regulatory Affairs will function as the representative for a multitude of new medical devices with a focus on the Cardiovascular therapeutic area. This person will play a key role in facilitating global registration and product development as a spokesperson communicating with regulatory agencies.
The ideal candidate will come from a strong Medical Device background with a multitude of experience in Class III, Cardiovascular devices, as well as a cross-functional background in clinical/regulatory and working expertise in FDA negotiations. This person will also possess the ability to mentor and lead teams with substantial interpersonal skills to help navigate challenges faced by a rapidly growing company.
- Cultivate and carry out new regulatory strategies for projects to contribute to expeditious development and timely registration.
- Plan, author, and review sections of all regulatory submissions with high regards to the Cardiovascular area. Documents include but are not limited to 510(k)s and PMAs.
- Lead, mentor, and motivate a team as the lead representative for Regulatory Affairs in a cross-functional setting.
- Directly interface with the FDA and other Health Authorities during challenging negotiations regarding the approval of novel medical devices.
- Rigorously review all documents intended for submission to the FDA.
- Establish project plan due dates and monitor change management activities to ensure timely execution.
Job Specific Skills:
- In-depth knowledge and understanding of FDA guidelines, specifically in relation to the development and registration of Cardiovascular products.
- Effective communication and leadership skills, as well as the ability to analyze and determine the impact of regulatory complications.
- Experience with regulatory filings for medical devices, as well as experience directly contacting and organizing meetings with the FDA.
- The ability to be a supervisor as well as a hands-on member of a fast-paced team.
Of course a raise in salary is always an added bonus, but the real driver for you will be the benefits of joining my client’s team!
· Be a leading representative for a fast-paced team within a cross-functional setting.
· Act as a coordinator for all Regulatory activity pertaining the Cardiovascular Medical Device area, both internally and externally within a deadline structure borne of your own influence.
· Work in a challenging environment where the most notable feature is consistent employee satisfaction and growth.
· Build and mentor your own team, and have the opportunity to build upon your extensive background for even further professional advancement.
A Bachelor's degree is required, as well as minimum of 10 years in medical device regulatory affairs with a specialization in Class III Cardiovascular devices. An advanced degree (Master’s or PhD) is also preferred.
Please contact Melissa Riggi at 212-719-7526 or firstname.lastname@example.org to be considered for this position!