Regulatory Affairs Specialist

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United States
Bridgewater, New Jersey
Posting date: 10 Apr 2019
RA.MJ.22661_1554916960

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Regulatory Affairs Specialist position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its New Jersey-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • You will support registration activities for the medical device portfolio in international countries
  • You will support the development of regulatory strategies for new product introductions in these markets
  • Collaborates with other functional partners to help drive the implementation of best practices and efficiencies in registrations and processes.
  • Researches and interprets regulatory requirements to develop and execute regulatory strategy. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.
  • You will work with the team in developing submission timelines, capacity planning & prioritization for projects assigned to you
  • Support project work within team and/or within the organization
  • Responds to product information requests and tenders
  • Represents Regulatory Affairs on cross-functional project teams

Skills and Requirements:

  • Bachelor's degree (science degree is preferred) with 3 - 5 years of work experience is required.
  • Previous experience in Regulatory Affairs in medical devices is required
  • Experience with international regulations is preferred.
  • Exhibits scientific and technical understanding of regulated medical device products is required
  • 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.

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 Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.

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.

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