Natus Medical Incorporated Oakville, Ontario
14 août, 2019Permanent - Temps plein
Description About Natus: Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions. Job Summary: The Regulatory Affairs Specialist specializes in understanding international regulatory requirements to support the proper design and development of medical devices. They work with product development teams to ensure that our products meet regulatory compliance standards for medical devices. In addition, the Regulatory Affairs Specialist is responsible for maintaining product registrations in all international markets. This role may be based out of Oakville, ON or Ottawa, ON. In this job, you will: Be responsible for supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies Maintain company registrations and device listings in the US, Canada and the EU Support/maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark Support and report departmental metrics and reports to executive management Provides support and backup for other QA/RA functions Supports internal/external audits and regulatory inspections, may conduct internal audits as assigned Assess regulatory impact for new products and/or modifications to existing products Develop and execute regulatory plans to support medical device design control process and satisfy international standards for electro-mechanical medical devices Qualifications: Minimum 2 years' work experience in Medical Device Regulatory Affairs, including specific experience following Device Design Controls and Risk Management Processes Bachelor's degree from four-year college or university, or equivalent combination of education and experience 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 Canadian Benefits Natus offers competitive salaries, a comprehensive benefits package that starts after 90 days of employment, paid holidays, generous paid time off plan (2 weeks to start, 7 sick days) and tuition reimbursement annually. 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 throughout the recruitment process please do not hesitate to contact our Human Resources Department.