Regulatory Engineer Job Description
Regulatory engineer
provides regulatory support for Engineering (RF requirements); contracts/bid and Sales (ISP requirements); business development and on tax matters.
Regulatory Engineer Duties & Responsibilities
To write an effective regulatory engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Creates technical test plans or reviews ODM test plans
Reviews technical data and makes recommendations to Dev
Proactively resolves design issues
Interacts with regulatory agencies to track changes, address compliance questions and issues
Provides thought leadership, guidance and advice in Wireless/RF
Set priorities within various projects based on approved program direction
Use robust analysis techniques and process knowledge to prioritize and manage project activities
Systems/ Process Development, Metrics & Information Systems
Materials Regulatory Compliance)
Evaluate current process & capability and gather requirements for future deliverables and develop gap analysis
Regulatory Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Engineer
List any licenses or certifications required by the position: EMC, EN, RC, UL, ISO, CDRH, FDA, EMI, ESD, CE
Education for Regulatory Engineer
Typically a job would require a certain level of education.
Employers hiring for the regulatory engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Education, Electrical Engineering, Mechanical Engineering, Medical, Computer Science, Business, Industrial Engineering
Skills for Regulatory Engineer
Desired skills for regulatory engineer include:
Environmental standards and policies
Land use and zoning procedures
Planning
Real estate acquisition and finance
Regulatory requirements
Local & regional zoning
Legal and financial terms and the ability to read and interpret contracts
Legal and financial terms and ability to read and interpret contracts
Requirements engineering
Quality Management Systems
Desired experience for regulatory engineer includes:
Help to refine / improve existing processes, information systems, metrics, tools, templates, to support compliance activities
GPO Talent/ Knowledge Management
Training development (process data, training materials, and training deployment).ex
Provide administrative support and maintenance of consistent standards within the project
Work with designated external regulating agencies, to appropriately influence the Standardization process
Be the Subject matter expert on all regulations for the product category
Regulatory Engineer Examples
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Regulatory Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of regulatory engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory engineer
- Manage and execute complex projects related to preclinical strategy and all phases of the regulatory approval process of medical devices in the UK and Europe in support of our clients
- Manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of our clients
- Assist RA Analysts by conducting timely complaint and MDR investigations
- Participate in telephone interviews with customers and field personnel, and by performing on-site visits
- Work with team members and microbiology staff relative to CDS-related complaints
- Provide technical support to technicians, complaint administration staff and production shop floor staff relative to technical investigations
- Participate in monthly complaint review and CAPA meetings
- Support Quality Management System (QMS) by performing periodic product, process, internal and vendor audits and facilitate preventative and corrective action activities (CAPA)
- Work directly with the OEM to facilitate corrective and preventive action activities (CAPA) related to quality problems identified through complaint investigations and/or other sources of quality data
- Participate in process validation and New Product / Repair Introduction activities as needed
Qualifications for regulatory engineer
- Testifying experience in trials, hearings, and/or before government panels is an asset
- The ideal candidate will be expected to continuously expand his/her own expertise through peer-reviewed publications
- M.D., J.D., or M.S./Ph.D
- Direct experience in a product development environment in medical devices is required, including working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments
- Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices
- Minimum of ten years of professional experience, with a minimum of five years as a consultant
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Regulatory Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a regulatory engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory engineer
- As needed, communicate with customers and field personnel, and perform on-site visits
- Perform complaint file closure in a timely manner
- Perform failure analysis and defect investigations
- Interact with complaint investigation teams to ensure investigation is completed in a timely manner
- Provide technical solutions to address and expedite product complaints
- Communicate with Internal/External customers to identify details related to complaint information and occurrence
- Review associated complaint records to ensure the applicable assessment, investigation and analysis records are appropriate and complete
- Perform disposition of incoming complaints requiring an RA investigation in a timely manner
- Apply systemic problem solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- As needed, provides specific complaint reports in database systems for the purpose of trend monitoring and/or complaint investigation and research assistance
Qualifications for regulatory engineer
- Proficiency in the operation of data acquisition equipment, or demonstrated capabilities in learning the operation of new equipment
- Familiarity with Hypergraph Analytical Software
- 3 years impact test engineering, focus on vehicle crash testing
- Familiarity with federal and 3rd party crash test regulations
- Able to work independently cooperatively in a team environment
- Collect, summarize and evaluate compliance performance metrics and works to identify improvement programs
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Regulatory Engineer Job Description
Job Description Example
Our company is hiring for a regulatory engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory engineer
- Provide guidance on regulatory requirements for achieving regulatory compliance, while supporting innovative, cost-effective designs and on-time, quality launches
- Develop and execute plans established to respond to those changes
- Collaborate with the Platform and System Engineering team product development teams providing design consulting to insure compliance to global EMI regulatory standards
- Recommend purchases and oversee maintenance of EMI facility test SW and equipment
- Own system safety and regulation requirement such as IEC/UL/GB/FDA/CFDA other regulations in worldwide into the specific design requirement for design team
- Own RAC(risk analysis and control) and CMT(cause mitigation table) maintenance
- Take the responsibility for testing and certification with external NRTL(Nationally Recognized Testing Laboratories) such as UL, CSA, ITS, TUV and China test lab to get the qualified report
- Manage & conduct all verification test internally related to safety and compliance verification
- Support product RA on all submitted documents for countries clearance promote and enhance the safety & compliance design concept inside of engineering team
- Responsible for product certification in areas of Regional codes, standards based on standards development processes
Qualifications for regulatory engineer
- Minimum of 1 year experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries is required
- Specific experience in complaint-handling activities is preferred
- Strong analytical, organizational, communication and interpersonal skills are essential
- Must be computer literate with experience in Microsoft Office
- General knowledge and application of technical and business concepts, procedures, and practices is necessary
- Must be able to interprets company policies and procedures to resolve issues
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Regulatory Engineer Job Description
Job Description Example
Our company is hiring for a regulatory engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory engineer
- Impact, communicate, and define requirements for emissions, noise, materials, and electrical safety that impact products, thereby enabling delivery of measurable comparative advantage to our customers
- Analyze new, unique, and difficult engineering problems by using Engineering Problem Solving skills and established tools like iDFMEA, Hazard Analysis, Fault Tree Analysis, and Pugh Matrix
- Determine product and component environmental worthiness and adherence through coordinated testing and evaluation of engine products
- Apply specialized knowledge of engineering principles and practices across various areas and projects by interpreting, communicating, and ensuring product codes, standards, and Emission regulations are adhered to as they impact company products including certification compliance of CI and SI engines
- Engage with Nationally Recognized Testing Laboratories (NRTLs) when there is a need for a new certification using Certification Project Management or to modify an existing certification
- Hold the NRTLs accountable for delivering on schedule in order to keep engineering projects moving forward
- Utilize knowledge of electrical system product design and operation to advise regarding modifications and testing to facilitate engine product compliance with emissions certification requirements
- Support end-users in their efforts to understand these requirements during the New Product Introduction phase
- Collaborate with product, reliability, engineering, and business functions in ensuring requirements are met
- Apply technical expertise on complex components or projects and participate as a key contributor accountable for project success
Qualifications for regulatory engineer
- Minimum of 2 years experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries is required
- Beginner knowledge of industry practices and standards is desired
- Knowledge of UL standards, EU directives and OSHA regulations including machinery standards and functional safety, NFPA 79, EN 60204, EN ISO 12100, IEC 61508, IEC 62061 and EN ISO 13849
- Experience supporting EMC and Safety programs by means of identifying equipment needs, documentation needs, support equipment needs, staging and support of equipment to be tested, debug capabilities
- Experience with PWB/PCB tools
- Experience with spectrum analyzer, ESD testers, EMC chambers, and electrical safety analyzers
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Regulatory Engineer Job Description
Job Description Example
Our company is looking for a regulatory engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory engineer
- Facilitate audits, ensure traceability in manufacturing is maintained, ensure certification reports are auditable, and follow up after audits to close any remaining issues needing attention
- Influence at department or program management level
- Troubleshoot complex problems and utilizes recommends 7 Step Problem Solving Technique to develop and implement effective solutions and propose innovative initiatives and projects
- Managing product agency approval for the Merrychef product range
- Conducting internal lab testing to ensure design meetings approvals requirements
- Being the VOE for all topics regarding Agnecy Approval of the Merrychef product range
- Assisting the product management team and advising on approavls related matters
- Attending AGM of approvals bodies (Bsi etc)
- Develop and coordinate strategy for vehicle material related issues
- Perform as subject matter expert (SME) for an assigned set of regulations for export markets
Qualifications for regulatory engineer
- Ability to manage time and effort to meet project milestones
- Experience working with Environmental requirements such as Energy Star, RoHS, WEEE, REACH
- Candidates must possess an in-depth working knowledge of domestic and international EMI regulatory standards as pertaining to ITE
- Demonstrated ability to work with minimal supervision in a team environment to provide EMI design consulting to development organizations, responsible for overall product EMI strategy, perform engineering evaluation tests/analysis, qualification and generate EMI global reports/submittals of complex ITE
- Ability to analyze and determine corrective action to complex EMI technical challenges with solution recommendations
- Bachelor’s Degree in Electrical Engineering with 6-8 years of relevant experience or equivalent combination of education and work experience