Regulatory Affairs Specialist Jobs Vacancy in Natus Medical Incorporated Oakville
Natus Medical Incorporated Oakville urgently required following position for Regulatory Affairs Specialist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Regulatory Affairs Specialist Jobs Vacancy in Natus Medical Incorporated Oakville Jobs Details:
JOB TITLE: Regulatory Affairs Specialist
Supervisors Job Title: Director QARA
Location: Oakville, Ontario, Canada
The job 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:
As appropriate, compile and generate CE mark Submissions / Significant Changes for submission to the Notified Body.
Involvement in the preparation and maintenance of Technical Files and Design Dossiers.
Assist with international registrations and submissionsof the products.
Involvement in the preparation and maintenance of internal procedures to ensure compliance to new or revised regulatory requirements.
Assist Director QARA in the preparation and maintenance FDA submissions including 510k's and PMAs.
Work with the Commercial Team and Natus Distributors, to ensure country specific registration activities are understood and appropriately addressed.
In conjunction with the complaint specialists and in a timely manner; identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
Interact with manufacturing, engineering, R&D and quality representatives on regulatory issues.
Support Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities and other global regulatory agencies.
Demonstrate and actively promote the highest level of professional regulatory discipline.
Support vigilance on regulatory data for a range of medical devices
Any other duties as required by your supervisor or manager.
Travel Required: Minimal
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
Possess a good working knowledge of regulatory expectations and industry practices, including industry standards for QSR, ISO13485, MDD, MDR, CMDR, JPAL, Brazil, Australia regulations .
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.
Ability to work within a team environment to achieve agreed company goals.
Work experience in a medical device company is advantageous.
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from distribution partners, regulatory agencies or members of the business community. Ability to effectively present information to management. English language fluency is required.
Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is regularly required to work at a keyboard and computer. Specific vision abilities required by this job include close vision and the ability to adjust focus.
The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include (close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus).
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Natus offers competitive salaries, comprehensive benefit 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 up to $5,000 annually.
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.
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 contacting our Human Resources Department.
At this time we do not require agency assistance.