Regulatory Affairs Specialist jobs in Eau Claire, WI
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
- Benchmark Electronics, Inc
-
Winona, MN
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:
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
Other information:
- 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
- 0-2 years of basic regulatory experience
Education:
Geographical Location: Minnesota:Winona
Physical Location: Winona, MN - Central (4155)
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 .
- 28 Days Ago
- University of Wisconsin System
-
Eau Claire, WI
FULL_TIME
- POSITION: Two full-time Coordinators of Student Activities positions are available in the Activities, Involvement, and Leadership Office beginning May 2024. The working title for this assignment is Co...
- 10 Days Ago
- Apollo Retail Specialist
-
La Crosse, WI
PART_TIME
- Can’t stand being stuck behind a desk? Like working solo? Good with your hands? We have the perfect job for you as a Service Technician! Go store to store and work independently to keep the furniture ...
- Just Posted
- TLN Worldwide Enterprises Inc
-
Tomah, WI
FULL_TIME
- DescriptionPosition Title: COVID Systems AdministratorAs an onsite Systems Administrator on our project, you will be supporting the Department of Veterans' Affairs. You'll analyze problem areas and op...
- 22 Days Ago
- Olive Garden
-
Onalaska, WI
OTHER
- For this position, pay will be variable by location - See additional job details and benefits below.Our Winning Family Starts With You! Check out these great benefits!Flexible schedules to help you ba...
- 8 Days Ago
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0 Regulatory Affairs Specialist jobs found in Eau Claire, WI area
- Perrigo
-
Eau Claire, WI
- Location: Eau Claire, WI, US, 54703 Perrigo Company is dedicated to making lives better by bringing Quality, Affordable ...
- 4/16/2024 12:00:00 AM
- Perrigo
-
Eau Claire, WI
- Location: Eau Claire, WI, US, 54703 Perrigo Company is dedicated to making lives better by bringing Quality, Affordable ...
- 4/16/2024 12:00:00 AM
- Hy-Vee, Inc.
-
Eau Claire, WI
- At Hy-Vee our people are our strength. We promise "a helpful smile in every aisle" and those smiles can only come from a...
- 4/16/2024 12:00:00 AM
- Xcel Energy
-
Eau Claire, WI
- ** Inside Sales Representative Job** Location(s): WI - Eau Claire; CO - Denver **Position Summary** The Inside Sales Rep...
- 4/16/2024 12:00:00 AM
- Kelly Science Engineering Technology & Telecom
-
Eau Claire, WI
- Kelly Science & Clinical is seeking a Quality Assurance Engineer near Eau Claire, WI. Direct Hire Shift: Monday - Friday...
- 4/16/2024 12:00:00 AM
- Capri Communities LLC
-
Eau Claire, WI
- ** $25 an hour Third Shift Caregiver** ** Capri Communities Account Test Site** ** Eau Claire, WI** **SUMMARY:** The Car...
- 4/15/2024 12:00:00 AM
- CSL
-
Eau Claire, WI
- Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical ...
- 4/13/2024 12:00:00 AM
- Energy Central
-
Eau Claire, WI
- **Location:** **Rqd Education:** **Rqd Experience:** 2 - 5 years Location(s): WI - Eau Claire; CO - Denver * Quarterly s...
- 4/12/2024 12:00:00 AM
About Eau Claire, Wisconsin
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