Regulatory Affairs Manager

Job type:
permanent
Start:
07/2015
Duration:
n.a
From:
Real Staffing
Place:
Offaly
Date:
07/01/2015
Country:
flag_no Ireland

Project description:
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I have a fantastic opening for a Regulatory Affairs Manager with a leading medical device company based in Co. Offaly. This is an excellent opportunity to join a growing company in a senior management position.

RESPONSIBILITIES:

-Manage a staff of Regulatory Specialists. Actively interview and hire regulatory candidates with the proper skill set needed to meet the company's strategic objective

- Manage a staff of Regulatory Specialists. Actively manage a staff of regulatory specialist by a performing twice year performance reviews, developing development plans and providing feedback to ensure regulatory staff members are achieving company's strategic objectives

- Actively address and ensure compliance with the requirements of FDA, CMDCAS, EU Medical Device Directive and other country specific regulations.

- Provide technical expertise and ownership responsibility for currency of device Technical Files and Design Dossiers.

- Support Rest Of World and Corporate RA Groups in product registration documentation submittals, including support of Manager regarding issue of document notarization/ authentication.

- Maintenance of Product Licences and expediting renewal or upgrading of same.

- Perform and maintain Risk Assessments on product and processes, per ISO 14971, leading team in successful completion of same.

- Actively participate in review activities of the Engineering change function, assuring changes are risk assessed, and provide sign-off on regulatory and all labelling changes.

JOB DESCRIPTION

- Support D-FMEA and P-FMEA process on established, proposed changes to or new processes, mitigating risk and controlling compliance to Risk Management and cGMP requirements.

- Conduct Internal QMS Audits with focus on regulatory compliance.

- Direct liaison with Competent Authorities, (IMB) and Product Safety Inspectors (i.e. UL) on product registrations and in facilitating of site inspections.

- Provide Promotional literature review (PMAP) to assure compliance with stated data to product specifications and regulatory requirements.

- Working with Corp or Division in preparatory support of 510(k)s, supplements and variations.

- Perform duty of Medical Specialist for products, assessing complaints/incidents to determine if they are considered reportable to relevant authorities. Ensure good root cause analysis and risk mitigation performed, to effect timely closure of reportable events.

- Obtain and evaluate PMS data, ensuring impacted files are updated accordingly, and any process or product changes necessary are effectively processed through the change system.

- Monitor trends in compliance market, updates to regulations, emerging standards and guidelines, providing effective and meaningful training and interpretive guidance to Teamon both these and company regulatory policies, procedures.

- Work closely with Quality Manager to effect roll-out of Quality / Regulatory Initiatives and Corporate SOPs.

- Provide RA and compliance expertise during any BSI or FDA Inspections

- Interpret regulations, provide regulatory guidance; Serving as internal expert on regulatory issues

- Perform other duties as may be assigned in support of compliance

QUALIFICATIONS

- Experience managing intermediate to small functional group

- Primary Degree in Mechanical or Electronic Engineering. A degree in a Science subject will suffice if candidate can demonstrate working knowledge of medical device regulations

- 3rd level qualification in Quality Assurance would be beneficial

EXPERIENCE REQUIRED

- Direct experience with ISO 13485 and FDA 21CFR820 essential.

- 2 years managing regulatory or equivalent staff. Ability to manage a team, recognise the team's strengths, development needs, and professional goals, and inspire them to succeed

- Minimum of 8 - 10 years' experience in ISO 13485, CMDCAS and FDA 21CFR820 regulated Medical Device manufacturing company, with Class I thru Class III (EU) and Class II (US) products.

- Successful demonstrable hands-on track record in Regulatory Compliance, including product registrations and submittals.

- Must have audit-facing experience with FDA and EU Competent Authorities

If you are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.