Regulatory Affairs Manager - Devices

and delivering strategic outcomes.

Responsibilities:

• Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans

• Lead and/or support JAPAC health agency engagements

• Lead and/or support JAPAC filing activities and associated health agency inquiries

• Support device design controls activities and documentation reviews

• Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region

• Perform change control regulatory assessments as it relates to JAPAC

• Develop and support implementation and maintenance of internal regulatory processes

• Perform device determination decisions for regulated items to be developed and/or used in JAPAC region

• Support supplier engagement teams and due diligence activities in the JAPAC region

• Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region

• Support regulatory compliance initiatives in the JAPAC region

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree; or

• Master's degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or

• Bachelor's degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience

Preferred Qualifications:

• Master's degree in regulatory affairs, engineering, or life sciences

• 6 or more years of experience in medical device regulatory affairs

• Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development

• Experience in drug delivery device or diagnostics device regulatory submission process

• Regulatory CMC specific knowledge and experience

• Mature project management and organizational skills

• Strong and effective oral and written communication skills

• Experience in Veeva Vault platforms

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