Regulatory Affairs Project Manager

Highly Competitive
  1. Permanent
  2. Project Manager
  3. United States
Raynham, Massachusetts
Posting date: 28 Mar 2019

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Regulatory Affairs Project Manager position. The organization prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions. The position is based in the firm's Massachusetts office, with the possibility of working remotely. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

The ideal candidate will have demonstrable global project management experience working with data entry contractors to support the growth and expansion of the database, along with strong organizational and communication skills.

Job Responsibilities:

  • Directing and managing regulatory approvals and ensuring the approvals are stored appropriately.
  • Defining goals and deliverables that support business objectives in collaboration with the team.
  • Developing processes and structure for the information flowing into and out of the database.
  • Identifying opportunities for improvement for future growth.
  • Managing the resources needed to achieve project goals.
  • Identifying and resolving issues and conflicts within the project team.
  • Proactively managing changes in the project scope, identifying potential issues, and devising contingency plans escalating as appropriate.
  • Establishing the process of company integration into the database and providing oversight of the day to day operations.
  • Supporting the entity integration around the world.
  • Maintaining good relationships with Regulatory Authorities, Regulatory Departments, and distributors and provide support to worldwide partners.
  • Controlling expenditure within assigned budget.
  • Ensuring that all appropriate Quality and HR policies/procedures are communicated, implemented, and adhered to in a fair and consistent manner within the Regulatory Department.
  • Resolving business partner concerns and project constraints.

To Apply:

  • At least a Bachelor's degree; a Master's degree preferred.
  • Demonstrable regulatory experience in the medical device industry, with EUMDR experience preferred.
  • A Green Belt or Black Belt Six Sigma Certification a plus.
  • Demonstrable relevant project management experience.
  • Proven Global Project leadership experience.
  • Excellent cultural awareness.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office, Concur, and Visio.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.