Senior Regulatory Affairs Consultant - Combination Products

Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional!

Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product expert to join the team This is an amazing opportunity for an individual who is looking 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 Consultant, 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, EU, Japan and China.

• 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 Qualifications7-10+ years’ experience in an industry-related Regulatory Affairs role gained from the Pharmaceutical/Biotechnology, CRO, or Consulting industries 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 20% internationally and/or domestically may be required EEO DisclaimerParexel 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.