Senior Regulatory Affairs Specialist

Recruiter
CREGG Recruitment
Employment Type
Permanent
Salary
Not disclosed
CREGG Recruitment logo

Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Reg Affairs Specialist 

 

Job Purpose

Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.

Responsibilities

  • Takes ownership for regulatory decisions impacting projects/ changes, and defends those decisions to other functions/ regulatory agencies based on sound regulatory knowledge

  • Provides strategic thinking to achieve desired regulatory objectives.

  • Provide technical review of information to support regulatory submissions/ product files to assure accuracy, clarity of presentation and compliance with applicable laws, regulations, or standards.

  • Ability to recognize and communicate risk.

  • Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.

  • Review and update of EU Technical Documentation.

  • Prepares FDA regulatory files such as PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks.

  • Review and approve documentation related to various aspects of the design control process e.g. product release and product labelling

  • Participate in Regulatory agency audits.

  • Liaise and provide support to regulatory colleagues in the International regions.

  • Demonstrate and actively promote highest level of professional regulatory discipline.

  • Liaises with both middle and senior management on any regulatory issues relating to their area.

 

What we’re looking for:

Required

  • Bachelor’s degree, preferably in a scientific or engineering discipline
  • Working knowledge of current and proposed EU regulations for medical devices
  • Experience with FDA submission e.g. PMAs, PMA Supplements and Amendments, 30 Day Notices, Annual Reports and 510ks

 

Preferred

  • 3+ years of professional work experience 
  • Strong project management skills (organized, meets deadlines, determines critical path items, good time management). Ability to effectively manage multiple projects
  • Strong oral and written communication skills
  • Strong proficiency with Microsoft Excel, Word and PowerPoint applications
  • Effective written and oral communication, technical writing and editing skills
  • Working knowledge of product development process and design control