Product Regulatory Compliance Specialist
1 month ago
Mark Andy, Inc. is seeking a highly skilled Product Regulatory Compliance Specialist to join our team at our Global Headquarters in Chesterfield, MO.
The primary responsibility of this role is to ensure that existing and future products comply with internal and external regulations & standards. In this role, the Specialist analyzes regulatory requirements and audits project designs, plans and processes to monitor compliance with current or upcoming regulations.
The Product Regulatory Compliance Specialist prepares required filings for approvals, to ensure the quality, correctness and collaborates with product teams to coordinate regulatory changes and support compliance actions. Additionally, the Specialist researches industry trends and recommends improvements in testing processes, labeling standards and technical literature for legal, sales and marketing.
Key Responsibilities:
- Assist in the interpretation and application of regulatory requirements relevant to product lines. Provides support in the preparation of regulatory submissions and documentation.
- Coordinate the collection and review of necessary documentation from relevant departments. Maintain and organize compliance documentation, including technical files, product specifications, and regulatory filings.
- Support the quality assurance team in the implementation of compliance protocols and procedures.
- Stay updated on regulatory changes and industry trends to ensure ongoing compliance. Analyze data to identify trends, risks, and opportunities for improvement in compliance processes.
- Assist in conducting product testing and evaluations to ensure compliance with industry standards.
- Monitor product compliance status and update tracking systems accordingly. Generate compliance reports and assist in compliance audits as necessary.
- Serve as a point of contact for internal teams regarding regulatory and compliance inquiries.
- Help develop and facilitate training sessions on regulatory compliance and product safety protocols.
- Schedule meetings, maintain records, and assist with project management activities.
- Collect, organize and administrate regulatory compliance documentation.
- Support requests for regulatory documentation from Sales, Service and Operations teams.
- Communicate with vendors, partners, and regulatory bodies to gather necessary information for compliance purposes.
Requirements:
- Bachelor's degree in a relevant field
- 5 years of experience in a regulatory or compliance role.
- Experience with ISO standards or other relevant certifications.
- Knowledge of quality management systems.
- Knowledge of International Compliance
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office Suite and compliance tracking software.
- Strong analytical and problem-solving skills.
What We Offer:
- Competitive Salary and Comprehensive Benefits
- Medical, Dental, & Vision Insurance Plans
- 401(k) Retirement Savings Plan
- Paid Holidays, Vacation, Floating Holidays & Sick Time
- Employee Assistance Program
- Short-term and Long-term Disability
- Life and AD&D Insurance
- Onsite Cafe and Employee Arcade
- Tuition Assistance
- Incentive Plans
- Pet Insurance
- Daily Pay Option
- Discount Programs
Work Environment:
Regularly required to sit, stand, bend, reach, climb, stoop, kneel, crouch and crawl and move about facility and/or customer's facilities. Frequent lifting up to 10 pounds.
Mark Andy, Inc. is an Equal Opportunity Employer. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
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