15h Left Regulatory Compliance Engineer III
3 weeks ago
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.
#J-18808-Ljbffr
-
Regulatory Compliance Expert
5 days ago
Burnaby, British Columbia, Canada Delta Q Full timeAbout Delta-Q TechnologiesDelta-Q Technologies is a pioneering company that develops and supplies battery chargers to original equipment manufacturers (OEMs) of electric vehicles and industrial equipment. Our innovative solutions enable the widespread adoption of environmentally friendly electric drive systems.We value perseverance, innovation,...
-
Regulatory Compliance Expert
14 hours ago
Burnaby, British Columbia, Canada T-Net British Columbia Full timeJob SummaryThe Regulatory Compliance Expert will be responsible for ensuring compliance with the North American Electric Reliability Corporation (NERC) Mandatory Reliability Standards (MRS). This involves strengthening BC Hydro's internal compliance program across multiple business areas, providing oversight for MRS CIP compliance, and managing internal...
-
Mechanical Engineer III
4 weeks ago
Burnaby, British Columbia, Canada Verathon Full timeCompany OverviewVerathon 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...
-
Regulatory Compliance Inspector
4 days ago
Burnaby, British Columbia, Canada Toronto Film School Full timeToronto Film School is a leading provider of film and television education. We are committed to excellence and innovation in our programs and services.About the RoleThe Regulatory Compliance Inspector will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key ResponsibilitiesEnsure compliance with regulatory...
-
Director of Research
3 weeks ago
Burnaby, British Columbia, Canada Verathon Full timeOur culture is built to encourage and empower talented people (like you) to find purpose and belonging while doing the most impactful work of their career. Explore our open roles below.Please click on the job title for more information, and apply from that page if you are interested.Director of Systems Integration and Test Engineering– Visualization...
-
Senior Regulatory
4 weeks ago
Burnaby, British Columbia, Canada Delta Q Full timeAbout Delta-Q Technologies:Delta-Q Technologies (www.delta-q.com) develops and supplies battery chargers to original equipment manufacturers (OEMs) of electric vehicles and industrial equipment. Delta-Q's unique blend of engineering capability in high-efficiency power electronics and embedded software design delivers innovative battery charging solutions to...
-
Senior Design Verification Engineer
2 weeks ago
Burnaby, British Columbia, Canada Verathon Full timeOur culture is built to encourage and empower talented people (like you) to find purpose and belonging while doing the most impactful work of their career. Explore our open roles below.Please click on the job title for more information, and apply from that page if you are interested.The Software Engineer III is responsible for contributing to fundamental and...
-
Packaging Engineer III
3 weeks ago
Burnaby, British Columbia, Canada Verathon Full timeCompany OverviewVerathon 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...
-
Senior Regulatory Affairs Specialist
5 days ago
Burnaby, British Columbia, Canada Delta Q Full timeAbout UsAt Delta-Q Technologies, we are passionate about creating a sustainable business and contributing to a greener future for the world. We strive to innovate and improve our products and processes when it's a competitive advantage.Job SummaryThe Senior Regulatory & Compliance Engineer is responsible for managing product compliance with international...
-
Regulatory Compliance Expert
5 days ago
Burnaby, British Columbia, Canada Evonik Full timeJob Overview:This role requires a highly skilled Quality Assurance professional to oversee the technical and compliance aspects of auditing at Evonik Vancouver Laboratories. The successful candidate will have significant experience in a GMP regulated environment and a proven track record of establishing and maintaining quality systems.Key...
-
Sterile Product Packaging Engineer
4 days ago
Burnaby, British Columbia, Canada Verathon Full timeJob Title: Packaging Engineer IIIAbout the Role:As a Packaging Engineer at Verathon, you will be responsible for designing and developing innovative packaging solutions that ensure the safety, integrity, and sterility of our medical devices. This role involves close collaboration with cross-functional teams, including product development, Quality Assurance,...
-
Auxiliary Power Engineer 15h Left
21 hours ago
Burnaby, British Columbia, Canada British Columbia Institute of Technology Full timeAbout BCIT">At British Columbia Institute of Technology, we put people at the core of everything we do. Our People Vision is built on the foundation of valuing, supporting, and connecting our people. In a complex and uncertain world, it's vital that our employees feel valued, supported, and connected.We champion a culture of innovation and global progress...
-
Product Security Engineer II
4 weeks ago
Burnaby, British Columbia, Canada Infoblox Full timeAt Infoblox, we're a leader in cloud-first networking and security services, empowering organizations to deliver network experiences that are inherently simple, scalable, and reliable for everyone.We're seeking a highly skilled Product Security Engineer II to join our Product Security team. In this role, you'll play a vital part in ensuring the security and...
-
15h Left Engineer I
3 weeks ago
Burnaby, British Columbia, Canada Evonik Group. Full timeResponsibilities:- Provide assembly, testing, engineering, and CAD support to the Process Equipment Design group.- Responsible for production of LIPEX lab-scale extruders (assembly, testing, packaging, and coordinating with shipping & receiving).- Responsible for inventory management to ensure all required LIPEX products, parts and materials are available.-...
-
Vice President, Quality and Regulatory Affairs
2 weeks ago
Burnaby, British Columbia, Canada Corporate Recruiters Ltd. Full timeWe are seeking an experienced Vice President of Engineering & Operations to lead and scale our engineering and production teams in RF communication systems. Reporting directly to the CEO, this role is responsible for aligning technical expertise with operational efficiency to ensure high-quality product delivery on time and within budget. We are a high-tech...
-
Software Engineer III
2 weeks ago
Burnaby, British Columbia, Canada Avature Full timeRole ID: 208024Worker Type: Regular EmployeeStudio/Department: CTO - EA Digital PlatformFlexible Work Arrangement: HybridDescription & RequirementsElectronic Arts creates next-level entertainment experiences that inspire players and fans around the world. Here, everyone is part of the story. A place where creativity thrives, new perspectives are invited, and...
-
Software Engineer III
2 days ago
Burnaby, British Columbia, Canada Avature Full timeRole ID: 208024Worker Type: Regular EmployeeStudio/Department: CTO - EA Digital PlatformFlexible Work Arrangement: HybridDescription & RequirementsElectronic Arts creates next-level entertainment experiences that inspire players and fans around the world. Here, everyone is part of the story. A place where creativity thrives, new perspectives are invited, and...
-
Intermediate Geotechnical Engineer 15h Left
4 weeks ago
Burnaby, British Columbia, Canada Exp Global Inc. Full timeBe our next Intermediate Geotechnical EngineerYour work environment at EXPIn this role, you will be a part of the Geotechnical team for Western Canada, based in our Burnaby office. Not only will you be given an opportunity to help bring local geotechnical projects to life, but you will also have a chance to collaborate with EXP team members across Western...
-
Quality Technician III
3 weeks ago
Burnaby, British Columbia, Canada Verathon Full timeCompany OverviewVerathon 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...
-
Civil Engineer in Training 15h Left
2 weeks ago
Burnaby, British Columbia, Canada Stantec Consulting International Ltd. Full timeCivil Engineer in Training - ( 250000XL )DescriptionMany of the world's top engineers and scientists come together in our Water business because they view a community's interaction with water a bit differently—as a single holistic system, rather than unconnected networks divided by jurisdictional boundaries. Working throughout the hydrologic cycle, we are...
