Regulatory Group Lead

Wexford  ‐ Onsite
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Description

I have an immediate opening for a Regulatory Affairs Group Lead with a leading medical device company based in Wexford. This is a fantastic opportunity to join a leading medical device company in a Senior Regulatory Affairs position.

The Senior Regulatory Specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation.

Accountabilities Include:
Ensuring continuous compliance with the following:
- FDA Quality System Regulation 21 CFR 820 (QSR)
- Medical Device Directive
- Health Canada Medical Device Regulations
- ISO13485 Medical Device Quality Management System
- ISO14971
- Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
- Any other applicable market regulation
- Provide advice on regulatory affairs requirements for all proposed changes to device design.

Compilation of regulatory submissions:
- PMAs,
- CE Mark registration,
- 510(k) registration,
- Technical Dossiers and similar applications and notifications annual reports, supplements and registrations.

Leading the preparation and direct all activities for:
- FDA inspections, ISO 13485 surveillance audits Corporate audits
- Internal audits (see appendix 1 for details)
- Customer audits (see appendix 1 for details)
- Customer complaint investigation, reporting, closure and trending and follow through on close out of any subsequent actions assigned.
- Support other sites with any queries relating to site that may arise during their audits.
- Review current technical product files for compliance to international requirements.
- Answer all customer regulatory requests and complaints.
- Act as regulatory affairs representative on product design and R&D redevelopment teams.
- Design and implementing quality systems improvements.
- Support plant validation documentation programs as required, ensuring records are maintained.

Required Skills:
- Ability to communicate and work with people inside and outside the department.
- Ability to supervise
- Ability to co-ordinate, plan and organise
- Rigorous attention to detail.
- Ability to work to deadlines and on own initiative.
- Excellent interpersonal skills
- Excellent verbal and written communication skills.
- Working knowledge of Excel and Word.
- Experience with USA regulatory requirements would be advantageous.

Required Experience
- College graduate with Engineering or science degree or equivalent experience.
- Qualified systems lead auditor for ISO 13485 and MDD compliance.
- Minimum of 3 years experience in a Medical device regulatory affairs role.
- Competent in preparing written communication and correspondence.
- Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical and legal professionals.
- Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues.

If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.
Start date
06/2015
From
Real Staffing
Published at
25.05.2015
Project ID:
910918
Contract type
Permanent
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