Regulatory Affairs Specialist - Medical Devices

  • Nesco Resource
  • Memphis, TN, USA
  • Aug 01, 2020
Full time Government

Job Description

Job Description:
In this role you will be part of a collaborative and energetic team working on a high profile and highly pivotal initiative for a top notch medical device and technology company. Your expertise will help guide the organization through regulatory compliance activities with the following activities:
Supporting the generation of Technical Files and Design Dossiers
Working with cross functional teams to deliver supporting documentation (IFU, DHF, CER etc.)
Demonstrating strong understanding of design control documentation and EU MDR requirements

Responsibilities:
Prepare and review technical documentation as well as work with relevant team to resolve issues.
Assist with preparing reference information for technical files

Requirements:
Good interpersonal/communication skills are essential.
Experience of providing Regulatory Advice to the business is essential.
Ability to handle multiple demands in a fast-paced environment.
Experience working with large and diverse groups. Strong understanding of EU medical device regulatory affairs preferred.
Competences: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills.

Education: Bachelors, or equivalent experience
Licenses/ Certifications: None required, ISO auditing or RACS preferred.


Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.