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Regulatory Affairs support the creation of longterm 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 onmarket 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 crossfunctional 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:
Bachelors degree with 57 years of experience in regulatory labeling or equivalent combination of education and experience .
5 year of demonstrated skills and ability in people management is
Ability to organize prioritize and direct regulatorybased work activities
Experience with invitro diagnostics including specific USDA regulatory knowledge is desired
You have excellent customer service and business relationshipbuilding 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 crosscultural work environment
Some travel may be
This role will require at least 2 days onsite per week
Salary range starting at $120000 based on experience
Opportunity for annual cash bonus
Health / Dental / Vision Benefits DayOne
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!
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.
If youre 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. Youll 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: values a diverse workforce and workplace and strongly encourages women people of color LGBTQ individuals people with disabilities members of ethnic minorities foreignborn 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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Required Experience:
Manager
Full-Time