Regulatory Affairs Coordinator

1 day ago

Stamford, Connecticut, United States Blue Star Partners LLC Full time
{"title": "Regulatory Windchill Coordinator", "description": "Job Overview

Blue Star Partners LLC is seeking a skilled Regulatory Windchill Coordinator to provide vital support to the Regulatory Affairs team. This role involves collaboration with various teams to facilitate the market release of products using the SAP/PLM system.

Key Responsibilities
  • Data Analysis: Gather and analyze data using Excel pivot tables and VLOOKUPs to ensure compliance with regulatory requirements.
  • Regulatory Records Management: Use Windchill application to pull regulatory approval records for assigned countries, create Excel tracking sheets, and validate metadata.
  • Metadata Validation: Leverage tracking sheets and templates to identify discrepancies in metadata fields such as approval dates, expiration dates, models, legal manufacturer, manufacturing facilities, and certificate numbers.
  • Windchill Updates: Update Windchill fields to match approval records and ensure consistency with GRL naming conventions.
  • Communication and Clarification: Identify and resolve discrepancies in approval records by communicating with in-country affiliates. Report any issues such as expired approval records, incorrect approvals, or missing models.
  • Compliance Checks: Conduct compliance checks and work with logistics partners and customers to ensure regulatory adherence.
Requirements
  • Education: High school diploma required.
  • Excellent problem-solving, communication, organization, and data analysis skills.
  • Proficiency in Excel, including pivot tables and VLOOKUPs, is essential.
  • Ability to prioritize daily tasks and maintain flexibility to adapt to changing priorities.
  • Capability to work both independently and as part of a team.
  • Ability to follow instructions and work with a mentor.
  • Experience in project management and customer service is preferred.
  • Understanding of EUMDR (European Medical Device Regulations) for compliance purposes.
  • Experience with SAP/PLM systems and regulatory approval processes.
", "lang_code": "en"}

  • Regulatory Affairs Windchill Specialist

    3 weeks ago

    Stamford, Connecticut, United States Blue Star Partners LLC Full time

    Job OverviewPosition Title: Regulatory Affairs Windchill SpecialistCompany: Blue Star Partners LLCLocation: Hybrid - Remote with occasional onsite requirementsContract Type: W-2Role Summary:The Regulatory Affairs Windchill Specialist plays a crucial role in supporting the Regulatory Affairs department by ensuring the accuracy of Global Regulatory Library...

  • Regulatory Affairs Specialist

    2 weeks ago

    Stamford, Connecticut, United States Vital Health America LLC Full time

    Job Summary:The Regulatory Affairs Specialist is a critical role within Vital Health America LLC, responsible for ensuring the accuracy and compliance of our products' labels with all relevant regulations. This position plays a key part in maintaining the company's reputation for quality and safety.Key Responsibilities:Label Creation and Review: Assist in...

  • Regulatory Affairs Specialist

    1 week ago

    Stamford, Connecticut, United States Vital Health America LLC Full time

    Job SummaryThe Regulatory Affairs Specialist is a key member of the Vital Health America LLC team, responsible for ensuring compliance with all regulatory requirements related to food and dietary supplement labeling. This role involves creating, reviewing, and implementing Nutrition/Supplement Facts panels and customer labels for contract formulations.Key...

  • Regulatory Compliance Coordinator

    2 weeks ago

    Stamford, Connecticut, United States Blue Star Partners LLC Full time

    Job DescriptionJob Title: Regulatory Windchill CoordinatorLocation: Hybrid (1 day per week onsite) – Local candidates onlyContract Type: W-2Hours/Week: 40 hoursRate: $40-$45/hour (Hours over 40 will be paid at Time and a Half)Scope of Services:The Regulatory Windchill Coordinator provides vital support to the Regulatory Affairs team by validating Global...

  • Regulatory Compliance Expert

    2 weeks ago

    Stamford, Connecticut, United States trak group Full time

    {"title": "Regulatory Compliance Specialist", "description": "Key ResponsibilitiesAs a Regulatory Compliance Specialist at Trak Group, you will be responsible for ensuring that all operations and products adhere to relevant regulatory guidelines, including ISO 9001, OSHA, EPA, and FDA requirements.Key AccountabilitiesMonitor and analyze relevant regulations...

  • Regulatory Compliance Specialist

    4 days ago

    Stamford, Connecticut, United States trak group Full time

    Regulatory & Environmental Compliance SpecialistAt Trak Group, we're committed to maintaining the highest standards of safety and compliance. As a Regulatory & Environmental Compliance Specialist, you'll play a vital role in ensuring our operations and products adhere to relevant regulatory guidelines, including ISO 9001, OSHA, EPA, and FDA requirements.Key...

  • Regulatory Compliance Specialist

    3 weeks ago

    Stamford, Connecticut, United States trak group Full time

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Trak Group. As a key member of our organization, you will be responsible for ensuring that all operations and products adhere to relevant regulatory guidelines.Key ResponsibilitiesMonitor and analyze relevant regulations, including OSHA, EPA, and ISO standards, to...

  • Compliance Manager

    2 weeks ago

    Stamford, Connecticut, United States Larson Maddox Full time

    Job Summary:Larson Maddox is seeking a highly skilled Compliance Manager to join our team. As a Compliance Manager, you will play a critical role in driving a compliance culture and ensuring the effective implementation and enforcement of Compliance policies and procedures.Key Responsibilities:Manage internal Compliance-related work from inception through to...

  • Regulatory Compliance Licensing Coordinator

    4 weeks ago

    Stamford, Connecticut, United States Della Infotech Inc. Full time

    Job OverviewSummary:A regulatory compliance licensing coordinator with extensive experience in documentation, federal regulations, and posting. This role involves managing a substantial portfolio of over 200 licenses without any lapses. Required skills include expertise in federal regulations, documentation, and a background in regulatory or legal...

  • Regulatory Compliance Analyst

    4 weeks ago

    Stamford, Connecticut, United States Point72, L.P Full time

    A Career with Point72's Regulatory Reporting TeamThe Regulatory Reporting division is tasked with overseeing all regulatory filings and obligations for the firm globally. This includes ensuring the completeness of the global inventory of filings, establishing process and workflow controls, creating policies and procedures, and delivering process measurement...

  • Manager of Regulatory Compliance Reporting

    4 weeks ago

    Stamford, Connecticut, United States Excel Partners, Inc. Full time

    Excel Partners, Inc. is seeking a Regulatory Reporting Project Manager to enhance the firm's governance across all global regulatory submissions and obligations.The Regulatory Reporting division is responsible for the preparation of reports, coordinating extensive cross-departmental submissions, overseeing the technology that supports regulatory filings, and...

  • Regulatory Compliance Analyst

    2 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Are you a compliance expert seeking a dynamic role in a thriving global organization? This position offers the chance to advance your career while gaining exposure to international markets and senior leadership.About the Company:A reputable and expanding publicly traded financial services firm is on the lookout for a skilled Compliance Testing Officer. The...

  • Regulatory Compliance Reporting Lead

    4 weeks ago

    Stamford, Connecticut, United States Excel Partners, Inc. Full time

    Excel Partners, Inc. is seeking a Regulatory Compliance Reporting Lead to enhance the firm's governance across all global regulatory submissions and obligations.The Regulatory Compliance team is responsible for the preparation of reports, coordination of extensive cross-departmental submissions, oversight of the technology that supports regulatory...

  • Regulatory Compliance Analyst

    4 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Position Overview:Are you an experienced compliance expert who excels in a dynamic and entrepreneurial global setting? This role offers the chance to advance your career while gaining exposure to international markets and senior leadership. If this resonates with you, the Compliance Testing Officer position at Smith Arnold Partners may be an ideal fit.What...

  • Regulatory Compliance Analyst

    2 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Are you a compliance expert ready to excel in a dynamic global setting? This role offers the chance to enhance your career while being recognized for your contributions. If you seek a position that provides insight into international markets and interaction with senior leadership, this Compliance Testing Officer role at Smith Arnold Partners may be the...

  • Regulatory Compliance Testing Specialist

    4 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Are you a compliance expert seeking a dynamic role in a fast-paced global setting? This position offers a unique opportunity to enhance your career while being recognized for your contributions. If you are interested in gaining exposure to international markets and collaborating with senior leadership, this Compliance Testing Officer role may be the perfect...

  • Regulatory Compliance Testing Specialist

    4 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Are you a compliance expert seeking a dynamic role in a fast-paced global environment? This position offers a unique opportunity to enhance your career while being recognized for your contributions. You will gain exposure to international markets and interact with senior management, making this Compliance Testing Officer role a compelling choice.What do...

  • Compliance Testing Officer

    3 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Are you a seasoned compliance professional seeking a challenging role in a dynamic financial services firm? Do you have a passion for regulatory compliance and a desire to work with a talented team? If so, this Compliance Testing Officer opportunity at Smith Arnold Partners could be the perfect fit for you.As a Compliance Testing Officer, you will play a...

  • Regulatory Compliance Testing Specialist

    2 weeks ago

    Stamford, Connecticut, United States Smith Arnold Partners Full time

    Position Overview:Are you an expert in compliance who excels in a dynamic, entrepreneurial global setting? This role offers a unique chance to enhance your career while being recognized for your contributions. If you seek exposure to international markets and senior leadership, this Compliance Testing Officer position may be the right fit for you.What...

  • Lead Analyst, Energy Solutions

    4 weeks ago

    Stamford, Connecticut, United States Sacred Heart University Full time

    Join Sacred Heart University as a Senior Energy Management AnalystAre you passionate about shaping the future of energy? At Sacred Heart University, we are dedicated to driving innovation and sustainability in the energy sector. As a recognized leader in the field, we are committed to fostering a collaborative environment that empowers our team members to...