As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product Consultant to join the team and, based upon the individual's experience, the team is open to a highly motivated Senior Regulatory Affairs Associate with a passion and desire to build upon their foundation of combination product experience or a combination product SME who wants 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.
Dependent upon previous experience, you may lead or support some/all of the following:
• 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
Qualifications
- At least 2+ years experience experience in an industry-related Regulatory Affairs role gained from the Pharmaceutical/Biotechnology, CRO, or Consulting industries for a Senior Regulatory Affairs Associate role; 4+ years relevant experience for a Regulatory Affairs Consultant role; 7-10+ years relevant experience for a Senior Regulatory Affairs Consultant
- 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
When appropriate, the ability to travel up to 20% internationally and/or domestically may be required
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
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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