Advanced Compliance Engineer; Medical Devices (Hybrid)

Job Description

Advanced Compliance Engineer; Medical Devices

Location:

An Eastern suburb of Cleveland, OH

Compensation:

Commensurate with experience and is a combination of salary and bonus potential.

Opportunity Summary:

The Advanced Compliance Engineer is a crucial role in the organization as the liaison between the the internal research and development engineering team and the external testing agencies to ensure products are designed according to industry standards and determine the full scope of external compliance testing required for the entire suite of products. Our client is a growing and financially strong global company with household name recognition in the medical device industry. Their products are used around the world in hospitals and operating rooms. This company is known for promoting from within, as well as developing their employees with opportunities to work on a variety of different types of products within the medical device industry.

Duties:

Responsible for planning the compliance activities of the New Product Development (NPD) project. Planning includes identification of deliverables, budget and resource requirements and schedule requirements. Coordinates with the Program Manager to ensure plans are integrated into the complete NPD Program Plan.
Ensures that in the planning phase the NPD Project Team identifies all applicable compliance standards. Also ensures that compliance requirements are adequately represented in the product requirements and design specifications, with the appropriate level of detail. Ensures that acceptance criteria are identified and are appropriate.
Supports R&D engineers by reviewing and evaluating designs for compliance with standards. Obtains any needed standards interpretations or clarifications from the appropriate subject matter experts, test agencies or regulatory bodies.
The Advanced Compliance Engineer will participate in and lead compliance related activities such as risk management, usability, test design and protocol development.
Facilitates evaluation and testing of new products to the appropriate standards by internal test engineers and technicians as well as external test agencies. Acts as the liaison between R&D and external test agencies.
Provides assistance to R&D in identifying and resolving non-compliance issues.
Provides consulting support to the Current Product Engineering department regarding applicable standards, requirements, and problem solving.
Stays abreast of changes to applicable standards. Provides, or arranges for training to R&D and Engineering staff as required.
The Advanced Compliance Engineer will also support the Regulatory Representative, but is not responsible for regulatory compliance (FDA, CE technical file) other than compliance with standards that may be required as part of regulatory compliance

Required Experience:

Bachelors degree in an engineering discipline is required
8+ years experience in medical device or another regulated industry. Minimum of 5 years within a regulated industry in a Compliance, Regulatory, or Quality capacity.
3+ years experience in an R&D or Product Development environment
Detailed, working knowledge of IEC 60601 (preferred) and/or IEC 61010 regulatory standards.
Familiarity with IEC 60601 Particular Standards preferred

Keywords: Advanced Compliance Engineer, Medical Devices, IEC 60601, IEC 61010, regulatory standards, FDA

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