Regulatory Affairs Manager jobs in Nashua, NH
Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Manager jobs
- Benchmark Electronics, Inc
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Nashua, NH
FULL_TIME
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Benchmark provides comprehensive solutions across the entire product lifecycle; leading through its innovative technology and engineering design services, leveraging its optimized global supply chain, and delivering world-class manufacturing services. The industries we serve include: commercial aerospace, defense, advanced computing, next generation telecommunications, complex industrials, medical, and semiconductor capital equipment.
Summary:
The Manager of Quality and Regulatory Systems will manage quality systems support by developing, implementing, and maintaining current and future product/process inspection and audits. May be responsible for site regulatory compliance and programs, and serve as divisional and Corporate Quality technical expert as required. Foster divisional teamwork within a continuous improvement environment.Responsibilities:
- Manages Quality Systems Support by developing, implementing and maintaining current and future Product/Process Inspection and Audits.
- Fosters teamwork within a continuous improvement environment and support implementation of global best practices.
- Responsible for ESD capability and programs and assuring compliance with and conformance to applicable ESD divisional requirements and commercial standards.
- Serves as Site Lead and technical support expert for external regulatory systems audits and customer audits/questions related to QSR and FDA requirements and other regulatory requirements.
- Assists with the development and implementation of regulatory policy and procedures compliant with required standards within the site and Corporate, as required.
- Develops, monitors and reports on key quality and performance indicators as related to Production/Process audit results.
- Stays up to date on latest and future regulatory requirements and quality standards, communicating with the division and corporation on compliance requirements, now and in the future and adjust strategies and processes accordingly.
- Champions selected continuous improvement initiatives.
- Monitors and evaluates Quality Control functions at suppliers and Benchmark facilities in order to assure components and materials meet or exceed requirements as defined.
- Develops a quality plan which includes quality control policies and procedures for all manufacturing processes.
- Lead the development of SOPs and work instructions and associated quality tools to improve product quality and to increase work efficiency Identifying opportunities for improvement and developing processes to ensure regulatory compliance and process robustness.
- Collaborate and influence cross functional peer leaders in order to obtain support for process improvements.
- Oversee the compilation and review of organizational Quality metrics to identify potential gaps or adverse trends.
- Coordinates corrective actions on in-house and field product quality problems
- Defines incoming and final inspection policies. Ensures employees fully trained on requirements.
- Drives equipment calibration procedures and adherence to schedules.
- Implements Company programs related to 5S and BAM.
- Responsible for the development and maintenance of the site’s business continuity plan.
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 WebEx 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.
- Use of discretion with the ability to gain trust of business leaders and others to discuss and respond to sensitive and business critical issues.
- Effective negotiation and problem-solving skills.
- Effective analytical, planning and organizational skills.
- Collaborate and influence cross functional peer leaders in order to obtain support for process improvements
- Solid financial understanding, risk analysis ability, relationship building and project management.
- 4 year College Degree or equivalent combination of education and experience as approved by executive management
- 8 years quality and regulatory experience; 3 years in a leadership role in a multiple or large site (600 employees and associated revenue/customer base)
- Possess and maintain technical expertise and knowledge of quality management systems, regulatory requirements and standards, specifically those related to business sector requirements such as ISO, QSR, FDA, etc. as applicable to contract manufacturing of electronic devices
- Ability to interpret, understand and communicate regulatory requirements as applicable to the Division, serving as topic expert as required in support of the corporation
- Capable of training regulatory and quality system requirements, concepts, auditing methods and quality procedures within the Division to support the Corporation, as required
- Collaborate and influence cross functional peer leaders in order to obtain support for process improvements
Education:
Geographical Location: New Hampshire:Nashua
Physical Location: Nashua, NH
Shift: Shift 1
Work Schedule: M-F 0800-1630
Full Time
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 careers@bench.com .
- 15 Days Ago
- Community College System of New Hampshire
-
Nashua, NH
FULL_TIME
- General Summary: Reporting to the President, the Student and Community Affairs Officer leads, directs and manages the recruitment, enrollment management, student life, and workforce development progra...
- 1 Month Ago
- Dairy Queen | Cow Enterprise of Salem Corp
-
Nashua, NH
FULL_TIME
- Pay Range: $16 - $20 / hr You are applying for a job with a franchisee of the Dairy Queen system and not American Dairy Queen Corporation or International Dairy Queen, Inc. Franchisees are independent...
- 15 Days Ago
- Subway - 55052-0
-
Nashua, NH
FULL_TIME
- As part of the Subway® Team, you as a Manager will focus on eight main things: Providing an excellent guest experience Ensuring that great food is prepared & servedKeeping our restaurants functional, ...
- 17 Days Ago
- Subway - 28681-0
-
Hudson, NH
FULL_TIME
- As part of the Subway® Team, you as a Manager will focus on eight main things: Providing an excellent guest experience Ensuring that great food is prepared & servedKeeping our restaurants functional, ...
- 1 Day Ago
- Apple
-
Nashua, NH
FULL_TIME
- SummaryPosted: Mar 13, 2024Weekly Hours: 40Role Number:200542546Do you have a passion for teaching and building relationships with others? Keeping an Apple Store thriving requires a diverse set of lea...
- 3 Days Ago
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0 Regulatory Affairs Manager jobs found in Nashua, NH area
- HireMinds
-
Waltham, MA
- Manager, Regulatory Affairs Waltham, MA *this job requires 3 days per week on-site in Waltham, MA Our client is a biopha...
- 4/18/2024 12:00:00 AM
- Pragmatic
-
Bedford, MA
- About Our Client: Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitm...
- 4/18/2024 12:00:00 AM
- Planet Pharma
-
Waltham, MA
- Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-fun...
- 4/18/2024 12:00:00 AM
- Hireminds
-
Waltham, MA
- Manager, Regulatory Affairs Waltham, MA *this job requires 3 days per week on-site in Waltham, MA Our client is a biopha...
- 4/17/2024 12:00:00 AM
- Pragmatic
-
Bedford, MA
- About Our Client: Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitm...
- 4/16/2024 12:00:00 AM
- Akston Biosciences Corporation
-
Beverly, MA
- Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
- 4/16/2024 12:00:00 AM
- Planet Pharma
-
Waltham, MA
- Job Description: The Manager/Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and cross-fun...
- 4/16/2024 12:00:00 AM
- Akston Biosciences Corporation
-
Beverly, MA
- Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
- 4/15/2024 12:00:00 AM
About Nashua, New Hampshire
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