Natus Medical Incorporated
Natus Medical Incorporated Gort County Galway Ireland
2 months ago
Regulatory Affairs Specialist - 9 Month Contract
Natus the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufacture and distribute a range of medical device products used in the diagnosis of human neurological disorders.
Location: Remote and/or Hybrid; Whatever works for you With an office in Gort, Co. Galway we offer flexible options to suit our staff.
• Dear Prospective Applicant, *Important*. If you could please note the following: This role is a 9 month contract offering supporting our global regulatory team in Gort, Co. Galway, Ireland. Thank you*
“The success of our company depends on our employees. This is where you come in”
The RA Specialist (9 Month Contract) requires the person to work... within the current regulatory environment and frameworks for all relevant markets that Natus wishes to market our products and to ensure in conjunction with the commercial requirements that all regulatory requirements for the individual markets are met and this involves a varied set of duties and responsibilities.
Essential Duties & Responsibilities:
Assist with planning and execution of the EU Medical Device Regulation (MDR) projects in conjunction with site lead. Review and interpret documentation related to the introduction of the MDR. Develop and maintain internal procedures to ensure compliance to MDR. Update procedures, processes product specific documentation using the Natus change control procedure. Demonstrate highest level of professional regulatory discipline to ensure continued compliance to regulatory requirements by interpretation of new medical device regulations Ensure compliance to MDR as well other medical device regulations and standards. Liaise with Corporate in the development and implementation of MDR processes. Preparation and maintenance of Technical Files and Design Dossiers. Promote awareness of the MDR throughout the organization through regular training/briefing sessions. Integrate with corporate requirements and promote synergy/consistency with other sites. Monitor and communicate progress of MDR project to ensure compliance with internal quality objectives. Maintains and enhances cross-functional team relationships. Have an understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO, MDD 93/42/EEC, FDA 21CFR Part , Canadian SOR-98-, Australian Regulatory Guidelines for Medical Devices (ARGMD), Brazil ANVISA Medical Device Regulations, and the Japanese PMDA regulations, EU Medical Device Regulation (MDR) /. As appropriate, compile and generate CE mark Submissions / Significant Changes for submission to the Notified Body. Execution of international registrations and submissions. Work with the Commercial Team and Natus Distributors, to ensure country specific registration activities are understood and appropriately addressed. Support Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities, MDSAP and other global regulatory agencies.
Education and/or Experience:
Bachelor's degree from college or university in an engineering or scientific discipline (Electronics, Mechanical or Chemistry Sciences, Physics or related) with minimum 1-2 years related experience and/or training in the MedTech industry; or equivalent combination of education and experience. Preferred: Possess a good working knowledge of regulatory expectations and industry practices such as industry standards QSR, ISO, MDD, MDR, CMDR, JPAL. Excellent organizational; problem solving; decision making; communication (oral and written); and influencing skills. The person must be a “self-starter” in terms of time and task management and be able to operate with minimal supervision. Six Sigma and Total Quality Management (TQM) knowledge and experience. MS Office Proficiency Ability to work within a team environment to achieve agreed company goals.
Here’s what you can expect:
Attractive salary package. Excellent career progression opportunities Health Insurance & Life Assurance cover Active Sports and Social club. Flexi time Flexible work location - % Remote in Ireland Option
Gort County Galway Ireland
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