Labeling Team Regulatory Specialist

Regulatory Affairs support the creation of long-term value for IDEXX by ensuring compliance with regulatory requirements worldwide. This Senior Regulatory Specialist will work within the Inspection and Compliance team responsible for USDA and CFIA regulatory submissions/support of Outlines Labels & Inserts facility inspections and product notifications for IDEXX products manufactured globally.

In this role you will primarily support 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 work with 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 support and coordinate the ongoing activities and demands of the design team.

What you can expect:

• Your primary goal will be to help coordinate 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 collaborate with the team to understand artwork changes and communicate with internal stakeholders in a timely manner.

• You will review labeling changes which may impact existing or ongoing licensing activity and routine label updates.

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

• You will work closely with Planning Purchasing and Production to ensure effective implementation of approved artwork.

• You will Support Global licensing and product support activities related to Outlines Labels & Inserts Manufacturing Overviews and Product Performance Summaries.

• You will provide support for official inspections and product notifications as needed.

What you will need to succeed:

• Bachelors degree with 5-7 years of experience or equivalent combination of education and experience required

• You have project management experience

• Demonstrated skills in organization and attention to detail is a must

• You are flexible and able to adapt to a fast paced high volume innovative work environment

• Knowledge of label design work is a plus

• 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 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

What you can expect from us:

• Salary range starting at $90000 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

Ifyourelooking for a rolethatllchallenge you offer a variety of work and learning while helping an amazing industrywedlove to hear from you!

Why IDEXX:

Were 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 10000 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.

Lets pursue what matters together.

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 prohibitedby local state or federal laws.

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

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