Antech Diagnostics
Regulatory Manager
Antech Diagnostics, Loveland, Colorado, United States, 80538
We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other’s growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.
Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.
Job Purpose/Overview
The Regulatory Manager plays a pivotal role in ensuring that our products and processes meet regulatory standards. This role leads and develops the Regulatory team focusing on compliance management and stakeholder engagement to ensure company operations appropriately align with national and international regulatory frameworks.
Essential Duties and Responsibilities
Develop and implement regulatory procedures to ensure compliance with USDA regulations, as well as national and international hardware, electrical, and software product standards.
Maintain updated knowledge of regulatory changes affecting the company and analyzing their impact on products and processes.
Liaise with USDA representatives, certification bodies, and other regulatory authorities, maintaining positive and constructive relationships.
Coordinate the preparation and submission of all necessary regulatory documentation and reports related to USDA and other regulations.
Conduct internal audits and compliance assessments to ensure ongoing adherence to regulatory requirements.
Work closely with product development teams to advise on regulatory considerations during the design and development phases of new product development.
Provide regulatory guidance and training to staff, enhancing company-wide understanding of USDA and other regulatory landscapes.
Manage and respond to regulatory inquiries, audits, and inspections related to USDA and hardware standards.
Education and Experience
Bachelor’s degree in engineering, science, or other related technical field.
At least 10 years of regulatory experience, with a focus on USDA or similar regulations, and a portion of which has been in a leadership role.
Knowledge, Skills and Abilities
Comprehensive knowledge of USDA regulatory requirements, as well as national and international standards for other products.
Demonstrated ability to interpret complex regulations and guide strategic decision-making.
Exceptional organizational skills, with the capability to manage multiple projects and deadlines efficiently.
Strong communication and negotiation skills, capable of effectively engaging with regulatory authorities and internal teams.
Proven leadership and project management abilities, with experience leading cross-functional teams towards regulatory compliance.
Working Conditions
The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak to use the telephone, make presentations, and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 15 pounds.
The associate will primarily work in a typical office environment including the use of cubicles, computers, and overhead lighting. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.
The associate may be required to work in a manufacturing space where personal protective equipment (i.e., bouffant cap, safety glasses, shoe covers, etc.) are required.
The Target Pay Range for this position is $110,000-$125,000 annually. At Mars, pay decisions are determined using factors such as relevant job-related skills, experience, education, training and budget.
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
Full-time employees are eligible for the following benefits and more:
Medical, Dental, Vision (multiple plans availab5,000le)
Basic Life (company paid) & Supplemental Life
Short and Long Term Disability (company paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Paid Time Off & Holidays
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
Several other health and wellness benefits
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
All Full-time associates are eligible for the following benefits and more:
Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement, please see our Career page at Antech Careers (http://careers.antechdiagnostics.com/us/en/affirmative-action) .
Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.
Job Purpose/Overview
The Regulatory Manager plays a pivotal role in ensuring that our products and processes meet regulatory standards. This role leads and develops the Regulatory team focusing on compliance management and stakeholder engagement to ensure company operations appropriately align with national and international regulatory frameworks.
Essential Duties and Responsibilities
Develop and implement regulatory procedures to ensure compliance with USDA regulations, as well as national and international hardware, electrical, and software product standards.
Maintain updated knowledge of regulatory changes affecting the company and analyzing their impact on products and processes.
Liaise with USDA representatives, certification bodies, and other regulatory authorities, maintaining positive and constructive relationships.
Coordinate the preparation and submission of all necessary regulatory documentation and reports related to USDA and other regulations.
Conduct internal audits and compliance assessments to ensure ongoing adherence to regulatory requirements.
Work closely with product development teams to advise on regulatory considerations during the design and development phases of new product development.
Provide regulatory guidance and training to staff, enhancing company-wide understanding of USDA and other regulatory landscapes.
Manage and respond to regulatory inquiries, audits, and inspections related to USDA and hardware standards.
Education and Experience
Bachelor’s degree in engineering, science, or other related technical field.
At least 10 years of regulatory experience, with a focus on USDA or similar regulations, and a portion of which has been in a leadership role.
Knowledge, Skills and Abilities
Comprehensive knowledge of USDA regulatory requirements, as well as national and international standards for other products.
Demonstrated ability to interpret complex regulations and guide strategic decision-making.
Exceptional organizational skills, with the capability to manage multiple projects and deadlines efficiently.
Strong communication and negotiation skills, capable of effectively engaging with regulatory authorities and internal teams.
Proven leadership and project management abilities, with experience leading cross-functional teams towards regulatory compliance.
Working Conditions
The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak to use the telephone, make presentations, and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 15 pounds.
The associate will primarily work in a typical office environment including the use of cubicles, computers, and overhead lighting. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.
The associate may be required to work in a manufacturing space where personal protective equipment (i.e., bouffant cap, safety glasses, shoe covers, etc.) are required.
The Target Pay Range for this position is $110,000-$125,000 annually. At Mars, pay decisions are determined using factors such as relevant job-related skills, experience, education, training and budget.
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
Full-time employees are eligible for the following benefits and more:
Medical, Dental, Vision (multiple plans availab5,000le)
Basic Life (company paid) & Supplemental Life
Short and Long Term Disability (company paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Paid Time Off & Holidays
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
Several other health and wellness benefits
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
All Full-time associates are eligible for the following benefits and more:
Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement, please see our Career page at Antech Careers (http://careers.antechdiagnostics.com/us/en/affirmative-action) .