Senior Regulatory Affairs Consultant
4 weeks ago
When our values align, there's no limit to what we can achieve.
Bring your regulatory expertise and passion for combination products to Parexel
Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies
Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product Senior Regulatory Affairs Consultant to join the team We’re looking for a combination product SME to partner with our clients in the very early stages of product development, use their expertise to help our clients develop their strategies, guide them along the regulatory pathway, and maintain post approval technical files.
As a Senior Regulatory Affairs Consultant, you will work on medical device projects with combination products and support regulatory submissions for all phases in the US and Canada. You will draw upon your depth of medical device expertise as related to combination products with experience in regulatory strategy/process/writing.
You will:
• Serve as a single point of contact for RA submission strategy and consulting.
• Liaise with local regulatory teams, Parexel global team and the Sponsor.
• Provide global regulatory intelligence.
• Provide labelling consultation.
• Support Medical Devices opportunities/proposals.
In addition, you will:
• Ensure global approaches to the device regulatory strategy of Drug-Device Combination products and Medical Devices with particular focus on the requirements in the US (FDA). EU, Japan and China would be a plus.
• Lead and/or support Drug-Device Combination products and Medical Devices development and global filing activities from a regulatory standpoint from initial product concept through the product life cycle e.g. clinical submissions, technical files, marketing applications, response to questions, post-approval submissions and Agency Briefing Documents.
• Understand and interpret global regulations/ guidelines relating to Drug-Device Combination products and Medical Devices.
• Convey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.
• Act as an advisor and partner with functional units on the implementation of Drug-Device Combination and Medical Device regulatory requirements.
• Provide device-related advice on data management systems
• Provide device-related advice on data management systems
Qualifications:
7-10 years + of experience in a CRO or industry-related environment; experience with FDA (another regulatory agency such as EMEA, MHRA is a plus); a depth of medical device expertise as related to combination products with experience in regulatory strategy/process/writing.
Past digital health or software as a medical device experience is a plus.
Previous experience with Class II/III devices
Previous experience with off the shelf devices and new devices (end to end)
Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred
Language Skills - At least fluent vocal and written English
When appropriate, the ability to travel up to 10-15% internationally and/or domestically may be required
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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