Regulatory Affairs Director jobs in Merrimack, NH
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director 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 .
- 21 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
- BAE Systems
-
Merrimack, NH
FULL_TIME
- Job Description Because this role involves a combination of collaborative/in-person and independent work, it will take the form of a hybrid work format, with time split between working onsite and remo...
- 16 Days Ago
- PMC Medical Group
-
Merrimack, NH
FULL_TIME
- Director of Operations Merrimack, NH, 03054 Job Summary The Director of Operations will be responsible for overseeing the day-to-day operations of the company, ensuring that all departments are workin...
- 18 Days Ago
- Avesta Systems
-
Nashua, NH
FULL_TIME
- The following statements are intended to describe the general nature and level of work being performed and are not intended to be a complete list of all responsibilities, duties and skills required. M...
- 19 Days Ago
- Bedrock Care
-
Milford, NH
FULL_TIME
- Housekeeping Director Shifts: Day Shift Monday - Friday Benefits: Competitive salary based on experience Health, Dental and Vision Insurance Paid Time Off Our company is currently recruiting an experi...
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0 Regulatory Affairs Director jobs found in Merrimack, NH area
- Dyne Therapeutics
-
Waltham, MA
- Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-tran...
- 4/24/2024 12:00:00 AM
- Fidelity TalentSource LLC
-
Merrimack, NH
- Job Description: The Role The Brokerage Risk team advises Fidelity s dynamic individual investor businesses building lif...
- 4/24/2024 12:00:00 AM
- Spectrum Health Systems Inc.
-
Shirley, MA
- Location:Souza Baranowski Correctional Center - Shirley, MA. Secure Adjustment Unit Program. Schedule: Monday - Friday, ...
- 4/24/2024 12:00:00 AM
- Genabio Diagnostics
-
Bedford, MA
- Position Overview: The employee works with the management team to • Oversee quality and legislative requirements of all ...
- 4/23/2024 12:00:00 AM
- Sanofi
-
Cambridge, MA
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Commi...
- 4/22/2024 12:00:00 AM
- Stratacuity: Proven Scientific Placement
-
Waltham, MA
- Location: Waltham, MA (Hybrid) Therapeutic Area: Auto-Immune Job Overview: This role involves developing regulatory stra...
- 4/21/2024 12:00:00 AM
- Genabio Diagnostics
-
Bedford, MA
- Position Overview: The employee works with the management team to Oversee quality and legislative requirements of all pr...
- 4/21/2024 12:00:00 AM
- ClinCrowd
-
Waltham, MA
- Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strate...
- 4/20/2024 12:00:00 AM
About Merrimack, New Hampshire
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