Apply on Employer Site

IDEXX · 2 days ago

Regulatory Operational Compliance Specialist

Westbrook, ME

Full-time

Hybrid

Mid Level

3+ years exp

IDEXX is an innovation leader in the Animal Healthcare industry, seeking a Regulatory Operational Compliance Specialist. This role focuses on ensuring operational compliance with regulatory and business partners while supporting veterinary and water diagnostics, involving responsibilities such as submitting import permit applications and managing product change risks.

BiotechnologyHealth CareLivestockVeterinary

Responsibilities

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

Qualification

Regulatory complianceDocument preparationRisk assessmentLife sciences knowledgeProblem-solvingCollaborationAttention to detailCommunication skills

Required

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

Preferred

Bachelor's degree or equivalent combination of education and experience required, in life sciences is preferred

3-5 years of experience in regulatory operational compliance

Benefits

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

Company

IDEXX

Glassdoor3.5

10,000+ people, one global focus - enhancing the health and well-being of pets, people, and livestock We are passionate about what we do at IDEXX – and why wouldn’t we be? When you’re working to raise the standard of care for pets, make drinking water safe for billions and keep our livestock population around the globe healthy and free of disease, it’s no wonder that what we do each day is more than just a job.

Founded in 1983

Westbrook, Maine, USA

10001+ employees