IDEXX-posted 1 day ago
Full-time • Mid Level
Hybrid • Westbrook, ME
5,001-10,000 employees

As a Regulatory Operational Compliance Specialist, you will be part of a team that ensures operational compliance with our Regulatory and business partners to support a portfolio of veterinary and water diagnostics in the Animal Healthcare industry. This is an opportunity to build and improve existing processes to partner with global trade and regulatory partners worldwide. Your primary responsibilities will include submitting import permit applications, supplier outreach, product change management/risk assessments, and supporting global licensing/registration activities as well as Global Trade Import/Export through product analysis and documentation. This is a hybrid role requiring being onsite at our Westbrook facility 8 days a month. What you can expect in this role: Coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met. Research scientific and regulatory information in order to write, edit, and review product documentation. Compile materials required for support of submissions, license renewals, and annual registrations. Keep informed of professional and global regulatory information. Performs the coordination and preparation of document packages to support regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Monitors and improves tracking/control systems. Partner with other regulatory personnel to keep abreast of regulatory procedures and changes that can impact operations. May direct interaction with regulatory agencies on defined matters. Recommends strategies for submissions of regulatory permits or approvals. What you need to succeed: Bachelor’s degree or equivalent combination of education and experience required, in life sciences is preferred. Self-starter, with ability to work independently, initiates and coordinate projects and meet deadlines within a changing, fast-paced environment. Strong collaboration and teamwork. Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills. Pays close attention to detail, handles confidential information with discretion and possesses a “can do” attitude. Goal and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships within an organization. Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk. Occasionally participates in process improvements across teams and organizations. In addition to your current areas of expertise, you will have the opportunity to learn and grow your skills within a wide variety of disciplines. What you can expect from us: Salary range starting at $72,000 based on experience Opportunity for annual cash bonus Health / Dental / Vision Benefits Day-One 5% matching 401k Additional benefits including but not limited to financial support, pet insurance, mental health resources, volunteer paid days off, employee stock program, foundation donation matching, and much more If you’re looking for a role that’ll challenge you, offer a variety of work and learning, while helping an amazing industry, we’d love to hear from you!

  • Submitting import permit applications
  • Supplier outreach
  • Product change management/risk assessments
  • Supporting global licensing/registration activities
  • Global Trade Import/Export through product analysis and documentation
  • Coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met
  • Research scientific and regulatory information in order to write, edit, and review product documentation
  • Compile materials required for support of submissions, license renewals, and annual registrations
  • Keep informed of professional and global regulatory information
  • Performs the coordination and preparation of document packages to support regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections
  • Monitors and improves tracking/control systems
  • Partner with other regulatory personnel to keep abreast of regulatory procedures and changes that can impact operations
  • May direct interaction with regulatory agencies on defined matters
  • Recommends strategies for submissions of regulatory permits or approvals
  • Bachelor’s degree or equivalent combination of education and experience required, in life sciences is preferred
  • Self-starter, with ability to work independently, initiates and coordinate projects and meet deadlines within a changing, fast-paced environment
  • Strong collaboration and teamwork
  • Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills
  • Pays close attention to detail, handles confidential information with discretion and possesses a “can do” attitude
  • Goal and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships within an organization
  • Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk
  • Salary range starting at $72,000 based on experience
  • Opportunity for annual cash bonus
  • Health / Dental / Vision Benefits
  • Day-One 5% matching 401k
  • Additional benefits including but not limited to financial support, pet insurance, mental health resources, volunteer paid days off, employee stock program, foundation donation matching, and much more
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