Regulatory Manager, Labeling Design Team

Regulatory Affairs support the creation of long-term value for IDEXX by ensuring product labeling compliance with regulatory requirements worldwide. This position will manage the team responsible for designing, revising, and regulatory submission of labels and inserts for IDEXX products manufactured globally.

As a Regulatory Manager, Labeling Design Team, you will manage the Label and Insert Team which is within IDEXX Worldwide Regulatory. This team creates labeling material for diagnostic test kits manufactured globally. A successful candidate will manage an experienced design team that supports artwork creation for new product launches as well as on-market products. We are looking for a highly motivated individual who will manage the ongoing activities and demands of the design team.

• Your primary goal will be to manage a team responsible for the overall process of the creation, approval, regulatory submission, and implementation of labels and inserts for diagnostic test kits manufactured in North America and Europe.

• You will coordinate and prioritize all artwork changes within the team and communicate with internal stakeholders in a timely manner.

• You will represent Regulatory Affairs on new product development as well as product support teams and provide guidance related to US and global labeling requirements.

• You will routinely interact with regulatory officials regarding USDA regulations for label and insert content.

• You will participate in large cross-functional projects where product labeling is impacted.

• You will work closely with Product Compliance, Employee Health & Safety, and global regulatory colleagues to ensure ongoing compliance.

What you will need to succeed:

• Bachelor's degree with 5-7 years of experience in regulatory labeling or equivalent combination of education and experience required.

• 5+ year of demonstrated skills and ability in people management is required

• Ability to organize, prioritize and direct regulatory-based work activities

• Experience with in-vitro diagnostics, including specific USDA regulatory knowledge is desired

• You have excellent customer service and business relationship-building skills

• You demonstrate reasoning, problem solving, and analytical skills to resolve issues

• You have project management experience

• You have strong verbal and written communication skills

• You are comfortable working in a cross-cultural work environment

• Some travel may be required

• This role will require at least 2 days onsite per week

• Salary range starting at $120,000 based on experience

• Opportunity for annual cash bonus

• Health / Dental / Vision Benefits Day-One

• 5% matching 401k

• Additionalbenefits including but not limited to financial support, pet insurance, mentalhealth resources, volunteer paid days off, employee stock program, foundation donationmatching, and much more

Ifyou'relooking for a rolethat'llchallenge you, offer a variety of work and learning, while helping an amazing industry,we'dlove to hear from you!

We're proud of the work we do because our work matters. An innovation leader in every industry we serve, we follow our Purpose and Guiding Principles to help pet owners worldwide keep their companion animals healthy and happy, to ensure safe drinking water for billions, and to help farmers protect livestock and poultry from disease. We have customers in over 175 countries and a global workforce of over 10,000 talented people.

So, what does that mean for you? We enrich the livelihoods of our employees with a positive and respectful work culture that embraces challenges and encourages learning and discovery. At IDEXX, you will be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement.

Let's pursue what matters together.

If you're thinking about relocating for this role, here are a few things to know about living in Maine (often called "Vacationland"). The Westbrook, ME area provides great access to active downtown areas and the outdoors, with the coast and numerous mountains and hiking trails nearby. You'll also find a number of large companies like ours in the area, creating a vibrant work culture.

You can learn more on the Portland tourism website: https://www.visitportland.com/visit/resources/moving-to-maine/

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.

While we appreciate our staffing partners, we are unable to accept unsolicited agency resumes.

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