Regulatory Affairs Specialist III
Apply NowCompany: Benchmark Electronics
Location: Nashua, NH 03060
Description:
At Benchmark, we are driven by our purpose: to innovate for a healthier, safer, and better-connected world to create a brighter future. When you join us, you become part of a team passionate about making a meaningful impact across various sectors, including commercial aerospace, defense, advanced computing, next-generation communications, complex industrials, medical, and semiconductor capital equipment. We prioritize career growth, fostering a culture that ensures you reach your full potential. At Benchmark, your work is purpose-driven, enabling you to create a positive impact on the world and make your career truly meaningful. You'll be part of a collaborative, diverse, and inclusive team that values your ideas and contributions.
Summary:
Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.
Responsibilities:
Participates and contributes to regulatory departmental management meetings and goal accomplishment
Serves as customer team liaison for customer audits/questions related to specification requirements
Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
Monitors and report on key quality and performance indicators as related to regulatory system conformance
Keeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices
Actively participates in continuous improvement initiatives
Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements
Participates with customer teams, supporting NPI and ongoing production needs related to regulatory requirements
Perform a comprehensive analysis of complex contract requirements to determine what quality characteristics are to be controlled; Manufacturing, Inspection, Test Equipment required; special controls for unique processes, special skills needed and the insurance of their proper application
Manage and lead the Division quality system to ensure it meets various certification requirements
Act as the primary resource during audits
Conduct regulatory activities and interact with regulatory agencies to ensure compliance
Research and keep appropriate parties updated on outside regulations, updates and changes
Identify and submit all pertinent information for submission for new product approval and monitor the regulatory status of new product developments
Assist in the development of software and process validation protocols
Perform advanced Quality System Regulation (QSR) training and related GMP's (Good Manufacturing Processes)
Participate on Quality Planning Committee
Coordinate internal and external regulatory audits and inspections
Perform QA systems final review
Maintain process and system audit procedures and perform internal quality system audits
Analyze and incorporate performance data into applications and other regulatory requirements
Lead department auditors in needed activities
Assist other Benchmark divisions as needed
Champion continuous improvement initiatives
May mentor and give direction to lower level employees in same job family
May function as designate to Quality Systems management in their absence
Other information:
Excellent written and verbal communication skills
Effective interpersonal skills
Effective multitasking skills and the ability to take on additional responsibilities as required
Effective organization and prioritization skills
Demonstrate high attention to detail
Ability to work with diverse groups
Demonstrates discretion, confidentiality, independent judgment and professionalism.
Ability to work with minimal supervision and guidance, exercising discretion and independent judgment.
Understanding of and ability to use continuous improvement tools.
Strong customer service and client focus
Working knowledge of productivity tools, including Microsoft Office products and Teams conferencing software
Demonstrated leadership and people management skills including ability to effectively coach and mentor employees at all levels.
Enthusiastic and motivational communicator with multi-cultural experience.
Demonstrates effective customer interface skills.
Excellent interpersonal skills with the ability to interact and influence individuals, internally and externally, across all levels, functions and geographies.
Effective negotiation and problem-solving skills.
Effective analytical, planning and organizational skills.
Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers' needs/products; electronic device contract manufacturing preferred
4 year College Degree or equivalent combination of education and experience as approved by executive management
5+ years of regulatory experience with high complexity key customers; 5+ years in a leadership role
Demonstrate the ability to interpret and communicate complicated quality system regulations
Ability to pass and obtain internal certifications for Quality Systems Auditor and Regulatory Auditor
Able to travel up to 20% of time including day, overnight and international as required
Ability to support a 24/7 global business operation as required
Education: 4 year College Degree or equivalent combination of education and experience as approved by executive management
Geographical Location: New Hampshire : Nashua
Physical Location: Nashua, NH
Shift: Shift 1
Work Schedule: M-F 0800-1700
Full Time
Export Control: This job position may include access to controlled information or technology covered under applicable U.S. export control laws. As such, employment for this job position may be contingent on either verification that an applicant falls under the definition of a "U.S. Person" (which includes U.S. citizens, U.S. lawful permanent residents, and those granted U.S. asylum or refugee status)or on the Company timely obtaining any necessary export license required under federal laws. The Company evaluates such export license situations on a case-by-case basis and may decline to proceed with a job applicant in its sole discretion since export license applications can take many weeks to be processed.
In our innovative environment, you'll work with cutting-edge technology, leading the way in engineering design and delivering world-class manufacturing services for products that make a real difference in the lives of others. At Benchmark, your career is more than just a job. It's an opportunity to be part of something bigger, where your work matters and helps shape a brighter future for everyone. Together, we will achieve extraordinary things.
Benchmark is an equal opportunity employer. We are bringing together a diverse workforce with unique talents, life experiences, cultures, and perspectives to promote an innovative, collaborative, and creative place to work. If you need assistance or an accommodation due to a disability, please email us at [redacted].
Summary:
Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.
Responsibilities:
Participates and contributes to regulatory departmental management meetings and goal accomplishment
Serves as customer team liaison for customer audits/questions related to specification requirements
Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
Monitors and report on key quality and performance indicators as related to regulatory system conformance
Keeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices
Actively participates in continuous improvement initiatives
Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements
Participates with customer teams, supporting NPI and ongoing production needs related to regulatory requirements
Perform a comprehensive analysis of complex contract requirements to determine what quality characteristics are to be controlled; Manufacturing, Inspection, Test Equipment required; special controls for unique processes, special skills needed and the insurance of their proper application
Manage and lead the Division quality system to ensure it meets various certification requirements
Act as the primary resource during audits
Conduct regulatory activities and interact with regulatory agencies to ensure compliance
Research and keep appropriate parties updated on outside regulations, updates and changes
Identify and submit all pertinent information for submission for new product approval and monitor the regulatory status of new product developments
Assist in the development of software and process validation protocols
Perform advanced Quality System Regulation (QSR) training and related GMP's (Good Manufacturing Processes)
Participate on Quality Planning Committee
Coordinate internal and external regulatory audits and inspections
Perform QA systems final review
Maintain process and system audit procedures and perform internal quality system audits
Analyze and incorporate performance data into applications and other regulatory requirements
Lead department auditors in needed activities
Assist other Benchmark divisions as needed
Champion continuous improvement initiatives
May mentor and give direction to lower level employees in same job family
May function as designate to Quality Systems management in their absence
Other information:
Excellent written and verbal communication skills
Effective interpersonal skills
Effective multitasking skills and the ability to take on additional responsibilities as required
Effective organization and prioritization skills
Demonstrate high attention to detail
Ability to work with diverse groups
Demonstrates discretion, confidentiality, independent judgment and professionalism.
Ability to work with minimal supervision and guidance, exercising discretion and independent judgment.
Understanding of and ability to use continuous improvement tools.
Strong customer service and client focus
Working knowledge of productivity tools, including Microsoft Office products and Teams conferencing software
Demonstrated leadership and people management skills including ability to effectively coach and mentor employees at all levels.
Enthusiastic and motivational communicator with multi-cultural experience.
Demonstrates effective customer interface skills.
Excellent interpersonal skills with the ability to interact and influence individuals, internally and externally, across all levels, functions and geographies.
Effective negotiation and problem-solving skills.
Effective analytical, planning and organizational skills.
Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers' needs/products; electronic device contract manufacturing preferred
4 year College Degree or equivalent combination of education and experience as approved by executive management
5+ years of regulatory experience with high complexity key customers; 5+ years in a leadership role
Demonstrate the ability to interpret and communicate complicated quality system regulations
Ability to pass and obtain internal certifications for Quality Systems Auditor and Regulatory Auditor
Able to travel up to 20% of time including day, overnight and international as required
Ability to support a 24/7 global business operation as required
Education: 4 year College Degree or equivalent combination of education and experience as approved by executive management
Geographical Location: New Hampshire : Nashua
Physical Location: Nashua, NH
Shift: Shift 1
Work Schedule: M-F 0800-1700
Full Time
Export Control: This job position may include access to controlled information or technology covered under applicable U.S. export control laws. As such, employment for this job position may be contingent on either verification that an applicant falls under the definition of a "U.S. Person" (which includes U.S. citizens, U.S. lawful permanent residents, and those granted U.S. asylum or refugee status)or on the Company timely obtaining any necessary export license required under federal laws. The Company evaluates such export license situations on a case-by-case basis and may decline to proceed with a job applicant in its sole discretion since export license applications can take many weeks to be processed.
In our innovative environment, you'll work with cutting-edge technology, leading the way in engineering design and delivering world-class manufacturing services for products that make a real difference in the lives of others. At Benchmark, your career is more than just a job. It's an opportunity to be part of something bigger, where your work matters and helps shape a brighter future for everyone. Together, we will achieve extraordinary things.
Benchmark is an equal opportunity employer. We are bringing together a diverse workforce with unique talents, life experiences, cultures, and perspectives to promote an innovative, collaborative, and creative place to work. If you need assistance or an accommodation due to a disability, please email us at [redacted].