Associate Director, Medical Devices - Global Regulatory Consulting

Updated: April 5, 2019
Location: London, ENG, United Kingdom
Job ID: 3642

Overview

Associate Director, Medical Devices - Global Regulatory Consulting – Commercial

Location: UK - London or Farnborough

You’re driven, resourceful, and above all else – remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.

Responsibilities

Responsibilities:

You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients.

This position is responsible for leading client projects and assisting in the day-to-day operations of Global Regulatory Consulting specifically in the area of medical devices and/or diagnostics. The incumbent may be responsible for managing staff.

  • Assist Business Development in discussing Regulatory Consulting services with prospective clients with a major focus on devices and/or diagnostics.
  • Assist in providing input into proposals especially for medical device/diagnostic clients.
  • Maintain current knowledge of regulations and guidelines including ISO standards and MEDDEVS.
  • Assure dissemination to other parties of relevant changes in regulations and guidelines and direct implementation of training, if necessary.
  • Provide strategic and operational advice to clients specifically in relation to medical devices and/or diagnostics in Europe.
  • Review/write critical strategic sections of documents prepared by/for clients specifically in relation to medical devices and/or diagnostics in Europe
  • Supervise Regulatory Consulting staff and manage teams as appropriate. Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching if required.
  • Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges.
  • Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
  • Ability to travel as required (approximately 25%

Job Requirements

Qualification Requirements

 Minimum of a degree in an appropriate subject.

  • Subject matter expertise in medical devices and/or diagnostics in the EU 
  • Experience in working to Good Clinical Practice or other applicable GxPs, ISO standards and MEDDEVs.
  • Effective project management / management skills.
  • Understands and adheres to quality management systems.
  • Computer literacy in MS Word, Excel and PowerPoint.
  • Functions with minimal direction in an independent manner and exhibits a ‘can do’ attitude.
  • Excellent communication and interpersonal skills, both written and spoken, with an ability to influence, convince and persuade others.

Interested in Syneos Health? Get In Touch