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Job Details

Regulatory Affairs Supervisor

Company: Thornshaw Recruitment
Location: Dublin, Offaly or Home based in Ireland
Reference: LD9789
Closing Date: 21 Jun 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global medical devices company, are currently recruiting for a Regulatory Affairs Supervisor for their RA EMEA division. This role can be home-based in Ireland or based in their office in South Dublin or the Midlands. This is a 6 month contract.

Requirements:

Our client, a global medical devices company, are currently recruiting for a Regulatory Affairs Supervisor for their RA EMEA division. This role can be home-based in Ireland or based in their office in South Dublin or the Midlands. This is a 6 month contract.

JOB FUNCTIONS
Leadership of key EMEA-RA Operational areas:
Post-Market Surveillance Operations for EMEA region
•    Prompt submission of Vigilance Reports
•    Collaboration with Business Unit, Service & Repair, Regional Commercial and other functions as required, to resolve Competent Authority Queries
•    Oversight of PR Product Holds, and active leadership in FSCA Planning, Execution, implementation and Close-Out
•    Authorized Representative Function
•    Interface with HPRA and other Competent Authorities on issues of compliance, documentation requests and regulatory queries and challenges
•    Application of key corporate and Patient-Recovery policies and procedures
Pre-Market Regulatory Operations:
Maintenance and surveillance of Manufacturer and Class I Registrations
Resolution of issues pertaining to provision of Certificates of Free Sale (COFSs) and related documentation to support market registrations.
In addition, the RA Manager EMEA will:
•    Coach/Mentor Associate RA Specialist;
•    Oversee Time and Attendance; holiday plans etc.
•    Submit Initial Vigilance Reports in absence of RA Specialist
•    Monitor and assess vigilance reporting decisions and response to Regulatory queries by pR teams
•    Produce regular and ad-hoc reports on throughput, timeliness of Vigilance Reports, and FSCA performance as required.
•    Ensure compliance with the Company’s Security, Health & Safety and Documentation-training policies and requirements.

Requirements:
•    Degree/Diploma in a scientific, engineering or related discipline
•    Minimum 3 years’ experience in a medical device regulatory role
•    Experience in Post Market Compliance
•    Fluency in the English Language.
•    Previous experience in management of direct reports
•    Ability to analyse data and information, and solve problems
•    Regulatory knowledge and experience of compliance with the Medical Device Directive (MDD); ability to interpret regulatory requirements and respond appropriately to Regulators and customers.
•    Good interpersonal skills; strength to uphold regulatory requirements with conviction.

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 27

Apply for this job: Regulatory Affairs Supervisor

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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