Senior Product Compliance Specialist at IDEXX Laboratories, Inc in Westbrook, Maine

Job Description:

As a Senior Product Compliance Specialist, you will perform a variety of regulatory compliance duties in support of the Product Compliance function within the Operations System team to support the creation of long term value for IDEXX by ensuring product compliance with regulatory requirements worldwide.

In this role you will:

• Coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met.


• Research scientific and regulatory product compliance information to assess status of existing products and products in development.


• Compile all materials required for submissions, certifications, and annual registrations.


• Keep informed of professional and global regulatory compliance information, both environmental and health or safety. Work with governmental regulatory agencies, trade associations, and external consulting firms.


• Work with the Senior Product Compliance Manager to determine, communicate and execute line of business strategies, by product portfolio, based on regional revenue.


• Perform the coordination and preparation of document packages for authorization dossier submissions for new and mature products to ensure alignment and compliance with local and regional da requirements as needed.


• Compile all materials required in submissions. Recommend changes for labeling, manufacturing, marketing and for regulatory compliance.


• Monitor and improve tracking/control systems. Keep abreast of product compliance regulations changes. May direct interaction with government agencies or trade associations on defined matters.


• Define requirements of regulations to work with Operations Systems teams to define Master Data requirements and recommend system updates.


• Recommend strategies for earliest possible changes in regulation with input from LOB

What you will need to succeed:

• Bachelor's degree or equivalent combination of education and experience required.


• Self-starter, with ability to work independently, initiates and coordinate projects and meet deadlines within a changing, fast-paced environment.


• Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills.


• Ability to pay close attention to detail, handles confidential information with discretion and possesses a "can do" attitude.


• Strategic-thinking, goal- and team-orientation, able to handle difficult issues in a professional, assertive and proactive manner and have a history of developing cross-functional relationships with all levels of an organization.


• Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk.


• Ability to facilitate and participate in process improvements across teams and organizations.


• Some travel may be required.

Why IDEXX?

We're proud of the work we do, because our work matters. Every role at IDEXX contributes to enhancing the health and wellbeing of pets, people, and livestock. With over 9,000 global team members, customers in over 175 countries, and a fast-growing industry - we're always looking for motivated and inspiring people to join us.

We offer competitive compensation, incentives, and benefits. You'll be part of a double-digit growth company in a quickly growing market and we are leading the way forward with innovative products, services, and a strong focus on our customers.

Let's Pursue What Matters.

IDEXX values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.

IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state, or federal laws.