Integer Regulatory Affairs Specialist in New Ross, Ireland
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
The regulatory and quality systems specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Employees are expected to support the quality concepts inherent in the business philosophies of Lake Region Medical including a variety of job related tasks which may not be specific to this position profile.
Accountabilities include: (see appendix #1 for detail)
The Regulatory & Quality Systems Specialist is responsible for:
Ensure continuous compliance with the following:
FDA Quality System Regulation 21 CFR 820 (QSR)
Medical Device Directive & Medical Device Regulation
Health Canada Medical Device Regulations
ISO13485 Medical Device Quality Management System
Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
All Internal Procedures
Assist with regulatory requests from customers and notified bodies, technical files etc.:
Assist with preparation and closing activities associated with:
United States FDA inspections
ISO 13485 audits (see appendix 1 for details)
Other Regulatory Agency Audits
Internal audits (see appendix 1 for details)
Process customer notification and regulatory requests
Support Quality system and regulatory system improvements activities
Be an active member of the Lake Region Medical Limited team and work with all associates to develop a world class lean manufacturing system.
Comply with the Lake Region Medical Limited behavioral standards.
Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements in your absence.
SKILLS AND KNOWLEDGE:
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.
Excellent attention to detail and organisation skills.
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.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
College graduate with Engineering or science degree or equivalent experience.
Qualified systems lead auditor an advantage
1-3 years experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
PHYSICAL & MENTAL DEMANDS:
- Work effectively with close tolerances.
Appendix 1: The Regulatory Specialist will provide support in the following:
- Regulatory Audits
Planning and Communication with Regulatory contact
Internal Planning and Communication & document co-ordination
Audit assistance for duration of audit
Communication & Feedback afterwards
Co-ordination of corrective action and response issuance
Training of internal personnel on audit techniques
Update of related slides for KPI
- Internal Audits
Assistance with completion of annual schedule
Review of audit reports and other documentation to ensure compliance to procedure
Carry out internal audits as per schedule
Drive improvements in Internal audit process and prepping auditors
Maintain of Internal audit documentation
Communication internally- Quarterly meetings and Plant KPI
- Customer and Regulatory Support
Completion of customer surveys and questionnaires in a timely fashion
Management of regulatory documents e.g. requested certs of free sale, apostilled certs
Keeping up to date with regulatory affairs as they affect LRI-changes to QA policy, Manual etc
Keeping up to date with current Regulatory requirements for e.g. FDA, E.U., Japan
Ensuring that the external standard documents as per master list are current
Supporting Regulatory related projects e.g. Design & Development scope addition for Lake Region Medical Limited.
Carry out Regulatory audits to ensure fulfilment of requirement for Design and Development scope
Update of procedures related to Regulatory requirements
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at