Regulatory Affairs Specialist

09 Nov 2019
07 Dec 2019
Contract Type
Full Time
Position: Regulatory Affairs Specialist
Location: Cardiff
Job Type: Permanent
Hours: 37 hours a week
The Role
An exciting opportunity has arisen for a Regulatory Affairs Specialist to join Arjo at offices in Cardiff to develop regulatory strategies for approval of products and new intended uses globally.
Key duties include:
  • In conjunction with project teams and international partners, establishes global registration to approve, develop, refine, and execute regulatory strategies to support business goals.
  • Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
  • Ensures applicable domestic and international regulations related to Risk Management.
  • Effectively manages projects by establishing project timelines to ensure effective resource management and to facilitate project review. Participates in product development teams as assigned.
  • Represents RA department in assigned project meetings with internal stake holders and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
  • Reviews and approves document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of assigned project teams.
  • Provides technical data/documents to the International Regulatory for the registration in Asia, Canada, Japan, Latin America, and other international areas.
  • Develops, prepares and submits high quality technical files, design dossiers and other necessary applications for regulatory approval in the US, Canada and Europe (CE Mark and local registrations).
  • Assess product and manufacturing changes and make regulatory assessments.
  • Represents and assesses company interests by participating and contributing in regulatory activities associated with trade and manufacturer associations, standards development groups, and government sponsored focus groups.
  • Assesses and provides strategies for draft legislation and regulations published for stakeholder consultation.
  • Assists in preparation for and participate in regulatory agency audits.
  • Under the direction of Regulatory Affairs management, executes regulatory aspects for any field corrective actions in a timely, thorough, and transparent manner.
  • Updates, reviews and assists in departmental procedures, policies as required
  • Reviews and approves labelling, product and process changes, and product documentation as it pertains to regulatory filings and clinical evidence.
  • Assists with the coordination of activities across departmental lines and between contractors or consultants to prepare product submissions, updates, and dossiers for regulatory agencies.
  • Participates in internal regulatory training for departments.