Regulatory Affairs Specialist

3 weeks ago

Oakville, Canada Natus Medical Incorporated Full time

**Regulatory Affairs Specialist**

***Oakville, ON**

**As a TEAMMATE**:
The **Regulatory Affairs Specialist** specializes in understanding international regulatory requirements to support the proper design and development of medical devices. You could expect to work with product development teams to ensure that our products meet regulatory compliance standards for medical devices. In addition, you could expect to be responsible for maintaining product registrations in all international markets.

*** **What you’ll get to do in this role**:

- 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.
- Update procedures, processes product specific documentation using the Natus change control procedure.
- Demonstrate highest level of professional regulatory discipline to ensure continued compliance to new or revised regulatory requirements
- Ensure compliance to MDR as well other medical device regulations and standards.
- 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%

**What we are looking for**:
**RA Specialist 2 Qualifications**
- Bachelor's degree from four-year college or university, or equivalent combination of education and experience
- Minimum 1 years’ work experience in Medical Device Regulatory Affairs, including specific experience following Device Design Controls and Risk Management Processes required.
- Working knowledge of FDA, Health Canada, EU, and International medical device regulations is required.
- Must be positive, a team player, transparent, and hold yourself and others accountable.
- Regulatory Affairs Certification (RAC) preferred.
- Experience with Electronic Medical Equipment preferred.

***RA Specialist 3 Qualifications**
- Bachelor's degree from four-year college or university, or equivalent combination of education and experience
- Minimum 3 years’ work experience in Medical Device Regulatory Affairs, including specific experience following Device Design Controls and Risk Management Processes required.
- Knowledgeable of FDA, Health Canada, EU, and International medical device regulations is required.
- Must be positive, a team player, transparent, and hold yourself and others accountable.
- Regulatory Affairs Certification (RAC) preferred.
- Experience with Electronic Medical Equipment preferred.

***
**Compensation and Benefits**: Natus offers a competitive salary, comprehensive benefit package that starts your first day, RRSP Match, paid holidays, paid time off plan (3 weeks vacation, 7 sick days each year), and tuition reimbursement up to $5,000 annually

***
**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.

INDNATUS

***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 a

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