Regulatory Affairs Manager – Digital Medical Devices, SaMD, (RTP, NC) (Code USA 041120)

Reference: Oli041120

Expiry Date: 30-12-2021

Category Clinical Research

Salary: Competitive

Job Type: Full Time

Wake County
United States

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Job Description

Regulatory Affairs Manager – Digital Medical Devices, SaMD, (RTP, NC)

This is a new, permanent Global Regulatory Affairs role based in Raleigh-Durham, NC. We are hiring for an internationally established and rapidly growing biotechnology company that is on the forefront of innovation.

Location: Raleigh-Durham, NC, USA.

Our client is a leading biotechnology company investing heavily (over 20% of turnover) in research and development of novel biologic and small molecule medicines across several therapeutic areas. To support its pipeline as well as already marketed products they are developing an array of medical devices from advanced drug-delivery systems for combination products to digital medical devices, software as medical device (SaMD), mobile apps and wearable sensors.

You would consider this role if you would like to work on variety of projects in a company that is financially healthy and has a successful track record in developing and marketing novel molecules. You will work with seasoned GRLs who have great deal of experience developing people, and will challenge and support you along the way of personal and professional growth.

Responsibilities will include:

  • Responsible for regulatory activities for both marketed medical devices and medical devices in development. These will be digital MDs, SaMD as well wearable sensors and medical mobile apps.
  • You will have the opportunity to help define the global medical devices regulatory affairs strategy
  • Responsible for preparation, planning, review and approval of submissions for digital devices as well as interacting and providing regulatory input to all HAs and NBs matters and questions in all regions.
  • Authoring, editing and preparing Technical Files and other documentation, including Real World Evidence studies and risk determination for clinical trials in order to obtain FDA clearance or CE Marks and NBs opinions.

The ideal candidate will have:

  • At least 4-5 years relevant experience in the pharmaceutical industry in a device capacity. Preferably, you will have 2-3 years’ experience with digital devices.
  • You will have knowledge in cross-regulations (drug-devices as well as device-data privacy or cyber security). Furthermore, you will have knowledge of software development in a GXP environment.
  • You will be result focused and performance driven person who is willing to learn and grow in an organization where individuals are judged on their own merits.

Package & Bens

My client offers a competitive salary, including a bonus, and incentives plan. The company is willing to consider individuals that want to work from home for 2 days a week post-Covid and is one of the first of our clients to recruit and on-board digitally at the start of the pandemic. Get in touch for more information.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov or Matt Greig on 855.505.1382 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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