Regulatory Specialist

The Regulatory Specialist will play a crucial role in ensuring that all snack products comply with food safety regulations and labeling standards. This position is responsible for both regulatory compliance and consumer complaint management, focusing heavily on food safety, quality assurance, and labeling accuracy. The role involves close collaboration with cross-functional teams to ensure compliance with FDA, USDA, and other food safety standards, while also handling private label customer complaints to improve overall product quality and consumer satisfaction.  This role will ensure the company's products meet the highest standards of food safety and regulatory compliance, addressing private label customer complaints while continuously improving product quality and safety processes.

Responsibilities:

Food Safety and Regulatory Compliance: 

• Ensure all snack products meet FDA, USDA, and industry-specific food safety...

Develop regulatory submissions for domestic and international spinal product clearances. Support our spinal product design teams concerning change control and spinal product regulatory submissions. Duties include:

1. Provide expertise on domestic and OUS regulatory strategies for products, including spinal devices, medical software (SaMD), medical devices containing software, radiation emitting devices, and cybersecurity;
2. Support design control activities for spinal devices, medical software (SaMD), medical devices containing software, and radiation emitting devices;
3. Apply IEC 62304 requirements during the development and improvement of the software lifecycle process for domestic and OUS submissions;
4. Prepare regulatory submissions, including 510(k) premarket notifications for the FDA;
5. Maintain FDA establishment listings and registration;
6. Prepare regulatory submissions, including technical files and design dossiers...

Reports to: Manager of Regulatory Affairs

Responsibilities:

• Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits.
• With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF).
• Generate and Review of Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheet, technical documents, RM composition breakdown, as may be required for local and international submissions.
• Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Heavy metal statement, Impurity statement, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement.
• Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH Compliant Statements, Global and regional Compliance statements, EU/China-compliant statement, etc....

Who is CorDx？  
 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  
 

Job Type: Full time  
Job Title: Regulatory & Compliance Specialist
Location: Onsite - San Diego

Salary Range: $90,000 - $95,000

Position Summary:

The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro...

Job Overview:

The Regulatory Specialist is responsible for ensuring compliance with regulatory requirements in the areas of food safety, labeling, and product registrations. This position requires a thorough understanding of relevant regulations and the ability to interpret and apply them to company policies and practices.

Responsibilities & Duties:

• Monitor and stay current on all relevant regulatory requirements and changes, including FDA, USDA, and international regulations.
• Ensure compliance with labeling regulations and review product labels for accuracy and completeness.
• Work with cross-functional teams to develop and maintain product specifications and ingredient lists.
• Coordinate and monitor product registration and approval processes.
• Prepare and submit regulatory documentation, including ingredient listings, food safety plans, and product registration files.
• Conduct...

Global Life Science Hub is partnering with an innovative pharmaceutical company in their search for a Regulatory Specialist. This company is dedicated to improving the quality of life for patients around the world by developing innovative and life-saving therapeutics.

The Regulatory Specialist will play a crucial role in ensuring compliance with regulatory requirements throughout the drug development process. The successful candidate will collaborate closely with cross-functional teams to provide regulatory guidance and expertise.

Responsibilities:

• Prepare and submit regulatory filings to health authorities, including INDs, NDAs, and other regulatory dossiers.
• Review clinical trial protocols, study reports, and other documentation to ensure compliance with regulatory requirements.
• Advise on regulatory strategies and identify potential regulatory risks and mitigation strategies.
• Stay current with changes in...

Who is CorDx？  

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  

Job Type: Full time  
Job Title: The FDA Compliance & Regulatory Specialist
Location: Onsite - San Diego

Salary Range: $66,560 - $100,000

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and...

Description

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist will also track and update FDA regulatory changes and collaborate with relevant departments to develop compliance training and policies.

Responsibilities and Duties:

• Familiarize and understand FDA regulations, guidelines, and requirements, ensuring alignment of the company's business processes.
• Participate in preparing and submitting FDA approvals and registrations, providing compliance support and document management.
• Oversee and manage the company's compliance program, including developing compliance strategies, processes, and operating procedures.
• Track and interpret changes in FDA regulations and guidelines, as well as relevant industry dynamics and trends.
...

About Verdant Specialty Solutions

Verdant Specialty Solutions is a global specialty chemical company. Its customers include world-leading personal care and home care brands, energy solutions providers, and industrial companies. Verdant’s vision is to be the go-to provider of batch specialty surfactant-based chemistry for applications in the consumer and industrial markets. Based in Houston, the company has nine locations in the US and Europe. Verdant is committed to safety, quality, and supply reliability.

Why Join Verdant?

Opportunities for growth Verdant is a fast-growing company that has the spirit of a small business. The company was formed in May 2021, so every employee plays an important role in culture and performance. It offers a dynamic ‘start up’ atmosphere with opportunities for professional growth.

Committed to safety Despite having the spirit of a small business, Verdant rivals...

The Tax & Regulatory Compliance Specialist plays a pivotal role in ensuring the organization's adherence to tax laws, regulations, and reporting requirements. Working within the accounting department, this position requires meticulous attention to detail, strong analytical skills, and a comprehensive understanding of tax codes and compliance standards. The specialist collaborates closely with internal teams, external auditors, and regulatory authorities to maintain accurate financial records and mitigate tax-related risks.

• Tax Compliance:
• Prepare and file accurate and timely tax returns, including income tax, sales tax, property tax, and other relevant filings.
• Stay abreast of changes in tax laws and regulations, ensuring the organization's compliance and identifying potential tax-saving opportunities.
• Assist in tax planning activities to optimize the organization's tax position and minimize tax...

Who We Are:

Global Healing Center is a leading manufacturer, distributor, and retailer of healthy living products, specializing in cleansing and detoxification. Our mission: create and market the best products possible, help as many people as we can through education, and provide customers with solutions to live a healthy lifestyle. Check us out at www.globalhealing.com if you are truly interested in working with us.

Here’s the Job:

We are seeking a results-driven Regulatory Compliance Specialist to implement and develop regulatory compliance strategies in the Dietary Supplement industry. You will be reviewing documentation and procedures, collaborating with internal and external stakeholders on compliance-related issues, and performing compliance audits.

Responsibilities: 

• Reviewing documentation, processes, and practices.
• Developing and enacting regulatory compliance...

Primary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance.

Essential Duties and Responsibilities

• Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
• Prepares regulatory submissions including 510(k) premarket notifications for US FDA
• Prepares regulatory submissions including technical files/design dossiers for registration of products in MDSAP countries and interfaces as needed with Notified Bodies regarding significant changes to products.
• Responsible for internal process improvements, data/metric evaluation, maintenance of internal and external databases, and public-facing information.
...