Slone Partners seeks a Director of Regulatory Affairs for an innovative and aggressively growing precision medicine company in Cambridge, MA. Our client is a world leader in molecular insights, connecting physicians and their patients to the latest cancer treatment approaches.
The Regulatory Affairs Director will be a key contributor in proactively developing, leading, and driving the execution of global regulatory strategy. As a leader in the organization, this individual is responsible for managing the RA team to work collaboratively towards defining appropriate regulatory pathways which align with corporate objectives. This includes bringing groundbreaking IVD and companion diagnostic products for therapeutics through the FDA and into the market. This market leading company has pioneered new technology that is focused on connecting physicians and their patients to the latest approaches in cancer treatment. Their ground breaking work is making precision medicine a reality for thousands of cancer patients.
Qualified candidates must have strong leadership skills with an established track record of developing regulatory strategy through FDA submissions for novel platforms.
Please note: Candidates must have 6+ years of experience working with CDRH including writing and submitting Pre-Sub, IDE application and/or PMA documents to FDA (CDRH).
Special features about this position: Reporting to the Vice President of Regulatory Affairs, this position is a highly visible role with one of the most exciting precision medicine companies in the country. This position is due to growth and the selected candidate will have a strong career development path.
If you meet these qualifications and wish to be considered for this position, please click on “Apply” and submit your resume.
All inquiries are kept confidential.
Internal Number: 3607
About Slone Partners
Slone Partners is a premier executive search firm that specializes in recruitment for the life sciences, diagnostics, data & analytics, and laboratory testing services industries.
Since 2000, Slone Partners has been chosen by innovative, world-class organizations to fill key positions with the best industry talent. Our extensive database of industry professionals, along with the knowledge of our executive recruiters, makes the presentation of the best candidates a Slone Partners standard.
AREAS OF EXPERTISE:
Clinical Trials / CRO
CMO / CDMO
Diagnostics / In-Vitro Diagnostics
Genomics / Molecular Diagnostics
Healthcare Information Technology
Laboratory Testing Services
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Contact us today at 1.888.784.3422 to discuss your hiring strategy and have access to the best talent to join your organization.
For more information on our services, visit our website: www.SlonePartners.com