Regulatory Affairs Specialist jobs in Nashua, NH
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Manager, Regulatory/Quality Systems
- Benchmark Electronics, Inc
-
Nashua, NH
FULL_TIME
-
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 .
- 22 Days Ago
Vice President of Student and Community Affairs
- 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
Billing Specialist
- Rightworks LLC
-
Hudson, NH
FULL_TIME
- Rightworks offers the only intelligent cloud purpose-built for accounting firms and professionals. Backed by award-winning around-the-clock US-based support, our fully managed IT and applications ensu...
- 21 Days Ago
Billing Specialist
- Nashua Eye Associates
-
Nashua, NH
FULL_TIME
- Billing and Reimbursement Specialist We are Currently Hiring! Nashua Eye Associates is an Ophthalmology Practice located in Nashua New Hampshire. We are currently looking for an energetic billing and ...
- 22 Days Ago
IT Specialist
- Sequel Medical Technology
-
Manchester, NH
FULL_TIME
- About SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.Job OverviewReporting to the Sr. Director, IT and Infrastructure, the Senior IT ...
- 22 Days Ago
Purchasing Specialist
- Reardon Associates
-
Merrimack, NH
FULL_TIME
- Merrimack, NH Reardon Associates is looking for a Purchasing Clerk to join our team. This position is responsible for the purchase of materials and supplies for the company. The ideal candidate will h...
- 2 Days Ago
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0 Regulatory Affairs Specialist jobs found in Nashua, NH area
Regulatory Affairs Specialist
- Atrium Medical
-
Hudson, NH
- Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
- 4/26/2024 12:00:00 AM
SVP, Investment Consultant Relations
- Fidelity TalentSource LLC
-
Merrimack, NH
- Job Description: The Role As a Senior Vice President, Relationship Manager (RM) you will cultivate relationships with th...
- 4/26/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Convatec Group PLC
-
Lexington, MA
- Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologi...
- 4/25/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Laborie Medical Technologies Corp
-
Portsmouth, NH
- We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters i...
- 4/24/2024 12:00:00 AM
QA/RA Specialist
- Walker Cole International
-
Boston, MA
- Walker Cole International is searching for a QA/RA Specialist to join a Global Medical Device business in Massachusetts,...
- 4/24/2024 12:00:00 AM
Associate Director/Director, Toxicology
- Keros Therapeutics
-
Lexington, MA
- Job Summary You will play a critical role in ensuring the safety and efficacy of our pharmaceutical biologics. You'll le...
- 4/24/2024 12:00:00 AM
Principal Regulatory Affairs Specialist
- Instrumentation Laboratory Company
-
Bedford, MA
- Key Accountabilities (Digital Factory Products)Conceive of and Implement the Regulatory Strategy in collaboration with C...
- 4/23/2024 12:00:00 AM
Principal Regulatory Affairs Specialist- USA Remote
- AngioDynamics, Inc.
-
Marlborough, MA
- Performs full-range of regulatory functions required for Global product registrations, new product development, and inte...
- 4/22/2024 12:00:00 AM
About Nashua, New Hampshire
Nashua is a city in Hillsborough County, New Hampshire, United States. As of the 2010 census, Nashua had a population of 86,494, making it the second-largest city in the state after Manchester. As of 2017 the population had risen to an estimated 88,341.
Built around the now-departed textile industry, in recent decades it has been swept up in southern New Hampshire's economic expansion as part of the Boston region. Nashua was twice named "Best Place to Live in America" in annual surveys by Money magazine. It is the only city to get the No. 1 ranking on two occasions—in 1987 and 1998.
Nashua is ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$82,334 to $110,341
Nashua, New Hampshire area prices
were up 1.4% from a year ago
were up 1.4% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020