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.
Essential duties and responsibilities include the following. Other duties may be assigned.
Ensures that all processes needed for the Quality Management System are established, implemented and maintained, including but not limited to: CAPA, complaint handling, documentation control, internal audit, management review, nonconforming product, production and process controls, and adverse event reporting. Promotes awareness of customer, quality and regulatory requirements throughout the organization.
Responsible for regulatory compliance with U.S., Canada, and the European Union requirements (FDA CFR, CMDR, ISO 13485 and MDD). Interfaces with FDA, notified bodies, and other regulatory authorities to ensure compliance with worldwide regulations.
Manages and develops team of quality and regulatory professionals. Provides appropriate mentoring, appraisals, and discipline of direct reports. Ensures that all direct reports are familiar with, trained on, and follow all Quality System procedures related to their jobs, and that changes to procedures are reviewed, approved and validated prior to implementation.
Implements corporate QA/RA objectives and procedures. Sets goals and objectives for business unit, and direct reports. Ensures that resources and activities are aligned with site, business unit, and corporate objectives.
Communicates progress, problems, and plans. Elevates issues requiring attention to QA/RA Management.
Responsible for strategic planning, staffing, and budgeting of QA/RA department activities and programs. Participates as member of strategic business unit management team.
Define, lead and manage the regulatory paths and any other regulatory requirements for the introduction of products to the market.
Travel Required:Moderate travel required to suppliers and other Natus facilities.
Supervisory responsibilities: Directly supervises up to ten employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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 four-year college or university is required or equivalent experience
Minimum of five years of experience in the medical device industry is required.
Experience managing quality systems is required.
Experience with US CFR Quality System Regulations, ISO 13485, MDD, CMDR required. Knowledge of ANVISA, MDSAP, J-PAL, CFDA a plus.
Experience with 510(k) clearances and technical file audits
Management experience in companies with US$100M annual sales is strongly desired.
Proven ability to grow and thrive in dynamic environment such as a multi-national, US-based company is required.
English language fluency is required.
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 customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups and/or boards of directors.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
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 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.
The noise level in the work environment is usually moderate.
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.
Additional Salary Information: Benefits:
Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually.
Natus is a leading provider of healthcare products and services used for the screening, detection, treatment, monitoring and tracking of common medical ailments in neurological dysfunction, epilepsy, sleep disorders, newborn care, hearing impairment and balance and mobility disorders.