A Major Medical Devices Company in Galway City, Ireland is seeking a suitably qualified person for the following post:
SENIOR REGULATORY AFFAIRS SPECIALIST
KEY RESPONSIBILITIES INCLUDE:
Directs or performs coordination and preparation of document packages for regulatory submissions.
Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Supports change control activities to support global approval and implementation of product and process changes
Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
May direct interaction with regulatory agencies on defined matters.
Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
Qualified to Level 8 Science or Engineering Bachelor's Degree/Masters with a minimum of 4 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.
Regulatory experience in Medical Devices and or Pharmaceuticals is required.
You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
You collaborate with others and create alignment with team members.
May provide guidance, coaching and training to other employees within job area.
You set high standards and drive accountability in the execution of your responsibilities and you model ethical behaviour.
You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.
REMUNERATION: Excellent Salary/Benefits Package on offer to the successful candidate.
APPLICATION: Please submit your CV in Word Format to:
INFORMAL ENQUIRIES: In strictest confidence to Christy O'Hara in Head Hunt International on 087-9473404 or 00353 87 9473404 (if outside Ireland)