Regulatory Affairs Manager

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• The Regulatory Affairs Manager, Gene Therapy CDx will apply regulatory expertise for Precision diagnostic products. • Lead preparation of submissions for global clearance of clinical trial assays. • Serve as regulatory lead on CDx program development project teams. • Design strategic approaches to support co-development programs. • Review development of analytical and clinical protocols for regulatory submissions. • Stay abreast of latest regulatory developments to communicate impact to project teams. • Support Precision’s post-market surveillance program

Requirements

• 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

Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation