Current jobs related to Regulatory Affairs Manager - New Britain - MicroCare LLC
-
Regulatory Affairs Associate Manager
7 days ago
New York, New York, United States Barrington James Full timeRegulatory Affairs Associate Manager/Manager - Hybrid RoleBarrington James is collaborating with a leading global pharmaceutical organization dedicated to advancing generic medications across various formulations and dosage forms. The company is expanding its operations and is in search of a Regulatory Associate Manager or Manager to contribute to its...
-
Regulatory Affairs Associate Manager
7 days ago
New York, New York, United States Barrington James Full timeRegulatory Affairs Associate Manager/Manager - Hybrid RoleWe are collaborating with a prominent global pharmaceutical organization dedicated to the development and distribution of generic medications across various formulations and dosage forms. The company is in a phase of growth and is looking for a Regulatory Associate Manager or Manager to enhance their...
-
Regulatory Affairs Associate Manager
7 days ago
New York, New York, United States Barrington James Full timeRegulatory Affairs Associate Manager/Manager - Hybrid RoleWe are currently collaborating with a leading global pharmaceutical organization dedicated to the development and market introduction of generic medications across various formulations and dosage forms. This expanding company is looking for an Associate Manager or Manager to enhance their Regulatory...
-
Regulatory Affairs Manager
3 weeks ago
New York, United States X4 Life Sciences Full timeA dynamic class II Medical Device client of X4 Life Sciences are looking for a skilled Regulatory Affairs Manager to join their team. With a range of new products launching this company are looking for a hands-on team leader who can maintain compliance to international medical device regulations. Responsibilities include:Maintain global regulations US, EU,...
-
Director of Regulatory Affairs
2 months ago
New York, United States Tandym Group Full timeA New York City-based healthcare network is currently seeking an experienced healthcare professional to join their leadership team in Queens as their new Director of Regulatory Affairs. Responsibilities:The Director of Regulatory Affairs will:Identify areas needing improvement and design continuous measurement of performance metrics and outcomesCreate and...
-
New Haven, Connecticut, United States Precision Life Sciences Full timeJob Title: Senior Manager of Regulatory Affairs OperationsCompany: Precision Life SciencesThis role is a vital component of the regulatory affairs division, reporting to the Senior Director of Global Regulatory Affairs. The primary focus is to manage the execution of regulatory strategies and ensure adherence to compliance standards, ultimately driving...
-
Lead Manager, Regulatory Affairs
7 days ago
New York, New York, United States AVON Full timeCompany Overview:LG H&H USA / The Avon is a prominent organization in the lifestyle and beauty sector, dedicated to helping our clients achieve their beauty aspirations. We embody our core values of Beauty, Health, and Refreshment, which resonate with our customers. As an innovative consumer marketing firm, we transcend traditional boundaries in household...
-
Regulatory Affairs Manager
7 days ago
New York, New York, United States Webster Bank Full timeAt Webster Bank, we are dedicated to fostering a culture that prioritizes people. Since our inception in 1935, our mission has been to assist individuals, families, and businesses in achieving their financial aspirations. As a prominent commercial banking institution, we are committed to serving our clients and uplifting our communities. Our core...
-
Regulatory Affairs Manager
2 days ago
New York, New York, United States Webster Bank Full timeAt Webster Bank, we believe in a career that is not just a job, but a pathway to making a difference. Established in 1935, our commitment to prioritizing people has been unwavering, as we strive to assist individuals, families, businesses, and our colleagues in achieving their financial aspirations. As a prominent commercial bank, we are dedicated to serving...
-
Regulatory Affairs Specialist
3 months ago
New Freedom, United States Sterling Life Sciences Full timeJob Description One of our top clients is recruiting again! They are looking for a Regulatory Affairs Specialist for their facility. Interested job seekers should have work experience with a highly successful and well-established medical device manufacturer. An overview of the Regulatory Affairs Specialist's responsibilities: 1) Be responsible for...
-
Lead Regulatory Affairs Consultant
7 days ago
New York, New York, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:The Senior Regulatory Affairs Specialist will engage with various business units to enhance and refine regulatory processes. This role involves assisting in the strategic implementation and operational activities related to regulatory affairs, including overseeing the...
-
Lead Regulatory Affairs Expert
7 days ago
New York, New York, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:The Senior Regulatory Affairs Specialist will play a pivotal role in enhancing and streamlining regulatory processes across various business units. This position is crucial for implementing strategic initiatives and operational activities within the regulatory affairs...
-
CMC Regulatory Affairs Manager
7 days ago
New York, New York, United States Katalyst HealthCares & Life Sciences Full timePosition Overview: We are seeking a qualified individual to take on the role of CMC Regulatory Affairs Manager within our esteemed organization, Katalyst HealthCares & Life Sciences. This position is crucial for the development of Chemistry, Manufacturing, and Control (CMC) documentation for our pharmaceutical products. Accountable for the preparation of...
-
Lead Regulatory Affairs Consultant
7 days ago
New York, New York, United States Intellectt Inc Full timePosition: Senior Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:The Senior Regulatory Affairs Specialist will engage with various business units to enhance and refine regulatory processes. This role is pivotal in implementing strategies and managing operations related to regulatory affairs, which includes overseeing the preparation of...
-
Head of Regulatory Affairs
2 months ago
New York, United States Merkle Science Full time⚡️ About Merkle ScienceMerkle Science provides blockchain transaction monitoring and intelligence solutions for web3 companies, digital asset service providers, financial institutions, law enforcement and government agencies to detect, investigate, and prevent illicit use of cryptocurrencies. Our vision is to make cryptocurrencies safe and provide...
-
Regulatory Affairs Consultant
2 months ago
New York, United States BioTalent Full timeA leading MedTech organisation are looking to add a Quality Assurance and Regulatory Affairs Consultant to their small team. The perfect candidate will be consulting on both Quality and Regulatory compliance issues and should have a problem solving attitude. 7 -10 years experience within the Medical Device industry is required, as is extensive experience...
-
Senior Regulatory Affairs Specialist
7 days ago
New York, New York, United States Innova Solutions Full timeInnova Solutions is currently seeking a Senior Regulatory Affairs Specialist. Position Type: Full-time; ContractDuration: 12+ MonthsLocation: Remote Compensation: $35 - $39/hr on W2 Role Overview: As a Senior Regulatory Affairs Specialist, you will play a crucial role in supporting our ongoing projects. We are looking for a candidate who is adept at learning...
-
Regulatory Affairs Associate
3 weeks ago
New Brighton, Minnesota, United States Danaher Full timeIn our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating...
-
New York, New York, United States EPM Scientific Full timePosition: Senior Manager of Regulatory Affairs for Advertising and PromotionCompensation: $190,000 to $220,000Overview: A leading global healthcare organization, committed to enhancing lives through innovative healthcare solutions across pharmaceuticals, medical devices, and consumer health products, is seeking a Senior Manager of Regulatory Affairs for...
-
Legislation and Regulatory Affairs Manager
7 days ago
New York, New York, United States Local Government Full timeManager of Legislative and Regulatory Affairs - Local GovernmentCompany: Local Government Position Overview:Position No: 15259Employment Type: Permanent - Full TimeDepartment OverviewOur agency is committed to serving the Western Australian community through diverse initiatives. We focus on facilitating engagement in various programs that encompass sports,...
![MicroCare LLC](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Manager
3 months ago
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:
- 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 company’s 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 R&D, 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 prioritization, 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.
- Represent the company as needed in industry associations, regulatory forums and working groups.
- Other duties as assigned.
COMPETENCIES/EXPERIENCE:
- Comprehensive understanding of domestic and international laws and regulations pertaining to chemical regulatory management – particularly TSCA, Canada DSL/NDSL, EU REACH, Korea REACH, UK REACH, etc.
- Ability to concurrently lead and/or manage multiple complex projects in a fast paced and complex environment
- Ability to challenge and influence decision making to diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc.
- Self-directed with strong analytical and problem solving skills
- Ability to effectively navigate and work within in a global and culturally diverse environment
- Effective leadership capable of managing and developing subject matter experts
- Detail-oriented mindset with the ability to analyze complex regulatory requirements and translate them into actionable strategies
- Strong organizational, analytical, and problem-solving skills, with an emphasis on Continuous Improvement / Process Optimization
MINIMUM QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job requirements below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
- Bachelor’s Degree in Science or Engineering, majoring in Chemistry, Chemical Engineering, Regulatory Affairs, Toxicology, Environmental Policy, or Environmental Science
- Minimum of 7+ years of experience in regulatory affairs within the chemical manufacturing industry, with expertise in EPA, FDA, REACH, F-Gas, DOT, IATA, IMDG, and hazardous materials regulations
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and regions
- Expert knowledge of SDS authoring, GHS Hazard Classifications, and labeling standards
- Must be knowledgeable in two or more of the following areas: Hazard Communication, Global Chemical Inventory and Substance Notification, OSHA, REACH, GHS, New Product Assessment, and other related global chemical control regulations
- Strong computer skills (i.e., Microsoft Office Suite, ERP- Chempax + and SDS software).
- Proven track record of successfully managing regulatory compliance programs and product registrations in a global environment
- Travel domestically and internationally as needed, 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
PREFERRED QUALIFICATIONS:
- Master’s degree, PhD in chemistry or related industrial science, or Juris Doctorate in Environmental Law
- Professional certifications (e.g., CRCM, RAC) and experience with electronic regulatory submission systems
- 10 or more years’ experience in chemical manufacturing product regulatory discipline.
- Experience participating with professional associations (e.g., AIHA, SCHC)
PHYSICAL/ENVIRONMENTAL QUALIFICATIONS:
- Sitting, standing, and typing for extended lengths of time.
- Continuous keyboard use / repetitive hand motion