Fulfilling the promise of precision medicine through quality and innovation.

Manager – Regulatory Affairs

ComplianceComplianceFull TimeRemoteTeam 1,001-5,000Since 2008H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

10 days ago

Salary

$124K - $152K / year

Bachelor Degree8 yrs expEnglish

Job Description

• Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies. • Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change. • Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management. • Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.

Job Requirements

Bachelor’s degree in a science-related area of study.
8+ years hands-on submission experience including the development and execution of regulatory strategies for medical device and/or IVD regulated products.
Strong understanding of product development processes, design controls.
Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.

Benefits

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

Related Categories

Compliance

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