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Senior Regulatory Affairs Consultant - Combination Products

USA - Any Region - Home Based Date posted 10/14/2021 Job ID 72379BR

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.

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
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

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

Qualifications

  • 7-10+ 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 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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