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MicroCare Corporation Regulatory Affairs Manager in New Britain, Connecticut

[Imagine working for a company that knows their employees are the key to its success, a company that provides exceptional results while being environmentally conscious and ahead of the curve in research and development; MicroCare LLC is that company. Since 1983, we have been a trusted global provider of critical cleaning solutions with a best-in-class employee population. Currently we are searching for a Regulatory Affairs Manager.

MicroCare, LLC is a distinguished ISO 9001:2015 registered enterprise renowned for its expertise in producing cleaning, coating, and lubricating fluids essential for the fabrication and installation processes across various sectors, including electronics, medical, fiber optic, and metal fabrication industries. Furthermore, we excel in developing specialized solutions for cleaning, coating, lubrication, and infection prevention, catering specifically to the dental, medical, and veterinary domains.

At MicroCare, we take pride in our pioneering efforts, having introduced numerous environmentally progressive and sustainable products, tailored to meet evolving regulatory requirements and the dynamic needs of our valued customers in the realms of cleaning, coating, and infection prevention.

[Voted Best Places to Work two years in a row, we are a company with heart. At all our facilities across the globe, we work in a cheerful, inclusive, and collaborative environment where we respect, encourage, and support our customers, our suppliers and each other. We like to laugh; have fun and we make an important impact.

MicroCare, LLC offers competitive salaries and benefits: Medical, Dental, Disability, 401k plan, Holiday and Paid Time Off. We strive to connect with, engage with and improve the lives of our employees, our customers, and the communities in which we operate. We are headquartered in central Connecticut.

**POSITION OVERVIEW: In this role you will be responsible for implementing and upholding a comprehensive regulatory compliance strategy that spans across diverse jurisdictions (EPA, FDA, REACH, F-Gas, DOT, etc.) incorporating regular audits, robust monitoring systems, and tailored training programs to uphold adherence to regulatory standards.

RESPONSIBILITIES:]{calibri",sans-serif"=""}]{#_Hlk98761365}

  • Monitor and interpret regulations pertaining to chemical manufacturing including EPA, FDA, Reach, F-Gas, DOT, and other relevant standards.
  • Assure product compliance with global chemical control legislation (including CARB, USA EPA SNAP, NA HAZCOM, TSCA, OSHA, EU REACH, WHMIS and ISO-10993 and provides GHS classifications).
  • Develop and maintain a compliance program to ensure adherence to applicable regulations across all company operations.
  • Conduct regulatory assessments and gap analyses to identify areas for improvement and ensure timely implementation of corrective actions.
  • Evaluate the impact of new legislation or rulemakings on chemical regulatory management programs and the companys diverse product lines and processes. Communicate with the appropriate departments regarding those issues and provide compliance guidance.
  • Manage the registration and approval process for chemical products in accordance with regulatory requirements in the USA, UK, Singapore, China, and other key markets.

Prepare and submit regulatory submissions including premarket notifications, registrations, and dossiers, ensuring accuracy and completeness.

Maintain comprehensive regulatory documentation including technical files, safety data sheets (SDS), and labeling to support product compliance and market access.

Collaborate with cross-functional teams including RandD, manufacturing, quality and legal to ensure regulatory compliance throughout the product lifecycle.

Review and advise on compliance during all phases of product development, commercialization, and portfolio maintenance, including formulation guidance, regulatory applicability determination and p ioritization, component and product classifications, impact and risk assessment and information management.

Identify and assess regulatory risks associated with new products, processes, and business initiatives to advise on risk mitigation strategies.

Coordinate and participate in regulatory audits, inspections and inquiries ensuring timely response and resolution of findings.

Monitor industry trends, best practices, and regulatory developments to proactively advise Leadership Team on upcoming regulations and standards affecting the industry.

Review and advise on marketing claims and intellectual property for MicroCare and competition.

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