Regulatory Affairs Specialist II - Structural Heart (on-site)

Abbott (abbottcareers2 board); New Brighton (MN); Sur place; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Free medical coverage

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Résumé du poste

Abbott is seeking a Regulatory Affairs Specialist II to join our New Brighton, MN team on-site. As an individual contributor, you will support regulatory submissions, prepare documentation for registrations worldwide, and assist in post-market change management to ensure compliance. You’ll work with cross-functional teams and align goals with department priorities.

You’ll also help implement GMP guidelines, draft clear regulatory communications, and coordinate with external agencies as needed.

Qualifications

• Bachelor’s degree or equivalent combination of education and work experience.
• 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, R&D/support, scientific affairs, operations, or related area.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.

Responsabilités

• Analyzes the input of cumulative product changes to current product submissions.
• Shares knowledge with others in department and on cross-functional teams.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• Prepares and aligns individual goals with department goals.
• Establishes and executes against project goals and implements plans.
• Follows GMP guidelines and procedures.

Connaissances

Regulatory experience

Cross-functional collaboration

Strong written/verbal communication

GMP knowledge

Formation

Bachelor’s degree or equivalent combination of education and work experience

Bachelor’s degree in science, math, engineering, or medical fields

Description du poste

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Structural Heart Business Mission: Why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

We are recruiting for a Regulatory Affairs Specialist II to join our team on-site in New Brighton, MN. As an individual contributor, the function of a Regulatory Affairs Specialist II is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide, with a strong focus on post-market change management.

What You’ll Work On

• Analyzes the input of cumulative product changes to current product submissions.
• Shares knowledge with others in department and on cross-functional teams.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• Prepares and aligns individual goals with department goals.
• Establishes and executes against project goals and implements plans.
• Provides input to establishing group plans and implementation of those plans.
• Follows GMP guidelines and procedures.
• Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences, particularly external regulatory agencies.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Signs-off at team level within delegated parameters for change control.
• Release authority for labeling/sales/promotional materials.
• Official correspondence with outside regulatory agencies are guided by supervisory staff.
• Conducts basic negotiations on routine product related issues with government agencies.
• Follows through on submission related activities to secure product approval.
• Directs own daily activities by utilizing team goals and division regulatory priorities.
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Obtains supervisory regulatory review on submission documents prior to submission to government agencies.

Required Qualifications

• Bachelor’s degree or equivalent combination of education and work experience
• 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.
• Apply business and regulatory ethical standards.

Preferred Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Certification is a plus (such as