Regulatory Compliance Engineer III
3 weeks ago
Company Overview
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.
Overview
Verathon is seeking a Compliance Engineer to become the newest member of the Regulatory Affairs/Quality Assurance team located in Burnaby, CA. This role will have primary responsibilities for defining and maintaining the compliance engineering requirements for product design and testing requirements and for preparing and maintaining Verathon product technical documentation files according to European Medical Device Directive (MDD 93/42/EEC) and European Medical Device Regulation (MDR) 2017/745. This position reports to the Manager, Regulatory Compliance.
Responsibilities
1. Define and provide compliance engineering requirements for product designs, updates and testing.
2. Manage and maintain Verathon’s worldwide standards database. Lead and/or partner with cross-functional teams to track and drive compliance activities to completion.
3. Liaise with external test houses (UL, CSA, Intertek etc.) and with notified bodies on compliance topics.
4. Author and maintain product technical documentation files according to European Medical Device Directive (MDD 93/42/EEC) and European Medical Device Regulation (MDR) 2017/745.
5. Provide front room and/or backroom support for external audits (such as FDA, Notified Body, etc.).
6. Support the performance of internal audits to determine compliance with Quality Management System (QMS) standards, policies and procedures, as well as regulatory and customer requirements.
7. Ability to work autonomously on specific compliance activities including projects and based business tasks, both planned and unplanned with accelerated timelines.
8. Manage NPD program as a Compliance Engineering SME. Collaborate with stakeholders to resolve compliance findings and observations in a timely manner.
9. Other duties as assigned.
Qualifications
1. Bachelor’s Degree in a Scientific or Engineering field required.
2. A minimum of 5 years’ experience in compliance and/or quality system activities in a QSR/ ISO 13485 Quality Management System and MDSAP audits.
3. Knowledge of the following regulatory requirements is required: GMPs, MDD / MDR, CMDR, TGA, ANVISA, PMDA.
4. Demonstrated experience with US, Canadian and other international product safety standards (i.e., ANSI, CSA, UL, EN, IEC).
5. The ability to complete regulatory reports and provide timely, written correspondence to internal and external customers including regulatory bodies.
6. Must have excellent oral and written communication skills with the ability to maintain composure under pressure.
7. Must possess strong organizational skills with the ability to manage time for completion of tasks across independent projects or program deliverables, while effectively balancing priorities.
8. Must have the ability to handle confidential data.
9. Must be a critical thinker and detail-oriented with strong problem-solving skills.
10. Strong desire to work within a collaborative, productive, and empowered cross-functional team.
11. Professional Engineer (P. Eng.) designation or eligibility for licensure in Canada.
Why Join Us?
Be part of an innovative team that is dedicated to improving patient outcomes.
Engage in meaningful work that makes a difference in the healthcare industry.
Competitive salary and comprehensive benefits package.
Salary range - $76,423 - $104,949 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
Verathon provides a competitive benefits package including a generous HCSA, paid holidays, paid time off and a retirement matching plan.
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