Precision Medicine Group · 1 day ago
Regulatory Affairs Manager
United States
Full-time
Remote
Senior Level
$95K/yr - $133K/yr
5+ years exp
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Responsibilities
Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision’s clinical trial assays and IVD-CDx products, including the preparation of regulatory submissions, meeting packages, and negotiations with regulatory officials as required
Serve as a regulatory lead on Precision CDx program development project teams, contributing toward DHF documentation, project plans and participating in meetings with pharma partners
Represent Precision in correspondence and meetings with regulatory agencies and Notified Bodies
Design strategic approaches to regulatory approvals, clearances, and post-market requirements to support co-development programs and reflect optimal business solutions for pharma partners
Review and direct the development of analytical and clinical protocols, technical reports, and other company documents for use in regulatory submissions and in response to queries from regulatory agencies globally
Review and edit regulatory communication, submission, timeline, and approval requirement documents for assigned programs and other initiatives
Stay abreast of latest regulatory developments on a global scale and communicate to the project teams for impact and possible implementation within Precision’s CDx programs
Perform regulatory impact assessment for any changes to clinical trial assays and CDx products for reporting to regulatory agencies
Support Precision’s post-market surveillance program
Qualification
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Required
BS Degree in Sciences, or equivalent in a Scientific, or similar discipline
Minimum of 5+ years of regulatory experience working in a medical device industry, specifically in-vitro diagnostics, preferably with gene therapy and/or CDx
Demonstrated knowledge and understanding of global IVD regulations, including but not limited to US, EU, UK, APAC, and MENA regions.
Strong written and verbal communication skills; highly proficient in spoken and written English is a requirement, proficiency in other languages is a plus
Ability to prioritize tasks, deadline-oriented, and good organizational skills.
Ability to think outside of the box and solve difficult problems with effective solutions
Committed attention to detail
Strong scientific and analytical skills
Strong leadership, team building and interpersonal skills
Direct experience working with small and large companies to design global regulatory and commercialization strategies
Experience managing staff members and project teams
Preferred
Master’s degree or Ph.D.
CDx experience
Class III IVD and LDT experience
FDA: PMA, IDE, and Q-Submissions
EU IVDR experience: Annex XIV, ethics committee submissions, and CE Mark
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
Founded in 2012Bethesda, Maryland, USA
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase
