Global Compliance Operations Manager

2 weeks ago

Wooster, Ohio, United States PRC-Saltillo Full time
Position Overview

Salary Range: $67,000 - $84,000

At PRC-Saltillo, we are dedicated to empowering individuals who face challenges in communication. Our innovative communication devices, software, and applications serve a diverse range of users, including those with autism, cerebral palsy, Down syndrome, ALS, and aphasia. Our goal is to enhance the quality of life for these individuals by providing them with the tools they need to express themselves and engage fully in society.

Qualifications

Education:

  • A Bachelor's Degree in business, engineering, quality assurance, or a compliance-related discipline is essential.
  • A minimum of five years of experience in manufacturing compliance, quality assurance, or corporate auditing is required.
  • At least one year of experience with the European Union Medical Device Regulation is mandatory.
  • Experience in the medical device sector is advantageous.
  • Familiarity with ISO 13485 standards is preferred.
Key Responsibilities
  • Develop and sustain a comprehensive understanding of compliance obligations related to current and future product offerings, ensuring adherence to all relevant laws, regulations, and compliance guidelines, including those from the European Union Medical Device Regulation (EUMDR) and the US Food and Drug Administration (FDA).
  • Prepare necessary documentation for laboratories conducting compliance testing and certification, collaborating closely with engineering teams during the testing phase to ensure products meet compliance standards.
  • Evaluate compliance testing recommendations from laboratories involved in product assessments.
  • Work in partnership with product design, development, and engineering teams to ensure clarity on product requirements, applicable regulatory standards, compliance strategies, and associated risks.
  • Assist product teams in prioritizing and implementing strategies to meet regulatory requirements for medical and consumer products across various markets, focusing on product design, development, market performance, and accessibility.
  • Maintain an up-to-date Library of Standards to ensure access to the latest compliance standards.
  • Oversee the management of the company's FDA Global Unique Device Identification Database, as well as European and Swiss Medical Device databases, ensuring accurate product support.
  • Responsible for creating and maintaining technical documentation, including risk analyses, declarations of conformity, technical files, usability study documentation, and related forms and work instructions to ensure compliance.
  • Act as a backup for document control systems, providing support, training, and improvement initiatives.
  • Perform additional duties as assigned.

  • Global Supply Chain Manager

    5 days ago

    Wooster, Ohio, United States Schaeffler Full time

    About the RoleSchaeffler is a leading global technology company that has achieved success through its entrepreneurial spirit and long history of private ownership. As a partner to major automobile manufacturers, aerospace, and industrial sectors, we offer numerous development opportunities. Your Key Responsibilities:Plan, initiate, coordinate, and monitor...

  • Senior Tax Compliance Manager

    1 week ago

    Wooster, Ohio, United States Jobot Full time

    Hybrid Remote Senior Tax Manager / 180K+ / BonusThis Jobot Job is hosted by: Christopher MildynA bit about us:We are a leading CPA and business consulting firm recognized for our exceptional workplace culture and commitment to employee success. Our firm has been honored multiple times as one of the best places to work, reflecting our dedication to fostering...

  • Restaurant Operations Manager

    5 days ago

    Wooster, Ohio, United States BellStores Inc Full time

    Job SummaryWe are seeking a highly motivated and experienced Restaurant Operations Manager to join our team at BellStores Inc. as an Assistant Restaurant Manager. The successful candidate will be responsible for supervising restaurant staff and daily operations to ensure that food safety, product preparation, cleanliness, and inventory control standards are...

  • Operations Manager

    5 days ago

    Wooster, Ohio, United States Summit Building Services Full time

    Job SummaryWe are seeking an experienced Janitorial Supervisor to join our team at Summit Building Services. As a key member of our operations team, you will be responsible for overseeing the daily activities of our janitorial staff and ensuring that our clients receive exceptional service.Key ResponsibilitiesClient Service: Work with employees to handle all...

  • Operations Manager: Home Healthcare Services

    3 days ago

    Wooster, Ohio, United States Safe and Secure Healthcare Full time

    **Job Title:** Operations Manager: Home Healthcare Services**Job Type:** Full-time**Location:** Nationwide**Salary Range:** $25 per hour**Job Overview:** As the Operations Manager for Safe and Secure Homecare, you will play a critical role in overseeing the day-to-day operations of our home healthcare services for individuals with intellectual and...

  • Cleaning Operations Manager

    1 week ago

    Wooster, Ohio, United States Summit Building Services Full time

    Custodial Team LeaderSummit Building Services is seeking a skilled and experienced Custodial Team Leader to join our dedicated team. This position involves working 36 hours per week, primarily in the evening hours, with a schedule from Monday to Saturday. The starting pay for this role is $18.50 per hour, and it includes a comprehensive benefits package...

  • Financial Operations Manager

    2 weeks ago

    Wooster, Ohio, United States Creative Financial Staffing Full time

    Financial Operations ManagerOverview of the Financial Operations Manager role and our client:This position is ideal for individuals interested in contributing to local government.Enjoy job security, comprehensive benefits, meaningful work, excellent retirement plans, and generous vacation time.Engage directly with local government leaders, collaborate across...

  • Financial Operations Manager

    2 weeks ago

    Wooster, Ohio, United States Creative Financial Staffing Full time

    Position: Budget ManagerOverview of the Budget Manager Position:This role is ideal for individuals interested in contributing to local government operations.Enjoy job security, comprehensive benefits, rewarding work, excellent retirement plans, and ample vacation time.Engage directly with local government leaders, collaborate across various departments, and...

  • Financial Operations Manager

    2 weeks ago

    Wooster, Ohio, United States Creative Financial Staffing Full time

    Position: Budget ManagerOverview of the Budget Manager Position:This role is ideal for individuals seeking a position within municipal governance.Enjoy job security, comprehensive benefits, and the opportunity to engage in meaningful work that contributes to the community.Collaborate with local government officials and various departments to enhance...

  • Restaurant Operations Manager

    5 days ago

    Wooster, Ohio, United States BellStores Inc Full time

    Job Summary:The Restaurant Operations Manager is responsible for supervising restaurant staff and daily operations to ensure that food safety, product preparation, cleanliness, and inventory control standards are maintained.Key Responsibilities:Supervise restaurant staff to ensure that food safety and operations standards are maintained.Coordinate and...

  • Tax Operations Leader

    1 week ago

    Wooster, Ohio, United States Jobot Full time

    Hybrid Remote Senior Tax Manager / 180K+ / BonusThis Jobot Job is hosted by: Christopher MildynAbout Us:We are a distinguished CPA and business consulting firm recognized multiple times for our exceptional workplace culture and employee satisfaction. Our accolades reflect our commitment to fostering successful careers and offering long-term opportunities for...

  • Operator III

    2 months ago

    Wooster, Ohio, United States Schaeffler Group USA Inc. Full time

    Schaeffler is a dynamic global technology company and its success has been a result of its entrepreneurial spirit and long history of private ownership. Does that sound interesting to you? As a partner to all of the major automobile manufacturers, as well as key players in the aerospace and industrial sectors, we offer you many development opportunities.Your...

  • Operator II

    2 months ago

    Wooster, Ohio, United States Schaeffler Group USA Inc. Full time

    Schaeffler is a dynamic global technology company and its success has been a result of its entrepreneurial spirit and long history of private ownership. Does that sound interesting to you? As a partner to all of the major automobile manufacturers, as well as key players in the aerospace and industrial sectors, we offer you many development opportunities.Your...

  • Machine Operator II

    3 days ago

    Wooster, Ohio, United States Schaeffler Group Full time

    About the RoleSchaeffler Group is a leading global technology company that values innovation and entrepreneurship. As a partner to major automobile manufacturers and key players in the aerospace and industrial sectors, we offer exciting opportunities for growth and development.Key ResponsibilitiesPrepare machines for production by tooling and parametrization...

  • HR Operations Coordinator

    5 days ago

    Wooster, Ohio, United States IDEX Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Human Resources Intern to join our team at IDEX. As an HR Intern, you will have the opportunity to gain hands-on experience in various HR functions, work in a collaborative environment, and receive mentorship from experienced HR professionals.Key ResponsibilitiesHR Operations: Assist with...

  • Logistics Operator III

    2 weeks ago

    Wooster, Ohio, United States Schaeffler Group Full time

    Schaeffler Group is a leading global technology firm that thrives on innovation and a rich legacy of private ownership. As a trusted partner to major automotive manufacturers and key players in the aerospace and industrial sectors, we provide numerous opportunities for professional growth.Your Key ResponsibilitiesManage the loading and unloading of materials...

  • Machinery Operator II

    2 weeks ago

    Wooster, Ohio, United States Schaeffler Technologies AG & Co. KG Full time

    Position Title: Operator II (Assembler) - TCC Assembly - 3rd ShiftCompany Overview:Schaeffler Technologies AG & Co. KG is a forward-thinking global technology enterprise, renowned for its entrepreneurial spirit and a rich legacy of private ownership. As a trusted partner to leading automobile manufacturers and significant players in the aerospace and...

  • Operator II

    2 months ago

    Wooster, Ohio, United States Schaeffler Group USA Inc. Full time

    Schaeffler is a dynamic global technology company and its success has been a result of its entrepreneurial spirit and long history of private ownership. As a partner to all of the major automobile manufacturers, as well as key players in the aerospace and industrial sectors, we offer you many development opportunities.Your Key Responsibilities Prepare...

  • Manufacturing Operator II

    2 weeks ago

    Wooster, Ohio, United States Schaeffler Full time

    Company OverviewSchaeffler is a leading global technology enterprise that thrives on innovation and has a rich legacy of private ownership. As a trusted partner to major automotive manufacturers and key players in the aerospace and industrial sectors, we provide numerous opportunities for professional growth. Key Responsibilities- Prepare machinery for...

  • Restaurant Operations Manager

    1 week ago

    Wooster, Ohio, United States Bluegrass Pizza dba Pizza Hut Full time

    Position Overview: Restaurant General ManagerAre you a natural leader with a passion for cultivating effective teams and providing outstanding customer experiences? We are seeking a seasoned professional who excels in recruiting, training, and guiding a successful team while maintaining a focus on objectives, team growth, and operational excellence. Elevate...