Regulatory Affairs Specialist
2 weeks ago
**Welcome to Natus Medical Incorporated**:
We’re 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.
***_“The success of our company depends on our employees. This is where you come in”_**
**Here’s what you can expect**:
- Hybrid work schedule out of Oakville, ON site
**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 ISO13485, MDD 93/42/EEC, FDA 21CFR Part 820, Canadian SOR-98-282, Australian Regulatory Guidelines for Medical Devices (ARGMD), Brazil ANVISA Medical Device Regulations, and the Japanese PMDA regulations, EU Medical Device Regulation (MDR) 2017/745.
- 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.
- **Travel**:up to 10% travel as needed basis
**Education and/or Experience**:
- Bachelor’s Degree in Quality/Regulatory or related discipline; an equivalent combination of education and experience can be considered
- At least 6 months' practical and relevant work experience in medical device Regulatory Affairs
- Possess a good working knowledge of medical device regulatory expectations and industry practices, such as industry standards QSR, ISO13485, MDD, MDR, CMDR, JPAL.
- Working knowledge of FDA, Health Paste Canada, EU and International medical device regulations
- Regulatory Affairs Certification (RAC) preferred.
- Possess strong Technical Writing ability.
- Have a methodical review approach, and be capable of initiating and leading change and continuous improvement.
- Clear Communication skills and English language fluency is required.
***Compensation and Benefits**: Natus offers a competitive salary, comprehensive benefit package that starts your first day, paid holidays, RRSP Match, paid time off plan (3 weeks vacation, 7 sick days each year), tuition reimbursement up to $5,000 annually, and Online Learning.
***
**We are PASSIONATE about**:
**Natus Medical Incorporated** is recognized by healthcare providers globally as **the** source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system. Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics and laboratories worldwide.
***EEO Statement**: _Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status._
***_Accessibility:_**
- _Natus is committed to creating an inclusive environment that accommodates all individuals, including those with disabilities. We support the goals of the Accessibility for Ontarians with Disabilities Acts (AODA) and have established policies, procedures and practices which adhere to the accessibility standards set out in the AODA. Should you require any accommodation
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