Regulatory Affairs Specialist II – Structural Heart

Abbott; New Brighton (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health coverage

Retirement plan with employer-contrib

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in New Brighton, MN is seeking a Regulatory Affairs Specialist II to support the regulatory department and ensure compliant processes. The position is on-site and involves preparing documentation for worldwide registrations with emphasis on post-market change management.

You will analyze product changes, coordinate with cross-functional teams, write regulatory submissions, follow GMP guidelines, and contribute to labeling and communications with agencies.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• 2–3 years in a regulated industry (e.g., medical devices, nutritionals).
• Ability to work in a team within a fast-paced, matrixed environment.
• Strong verbal and written communication across multiple levels.
• Judgment within defined practices and policies for regulatory solutions.
• Knowledge of regulatory avenues and ethical standards in business.

Responsibilities

• Analyze input of cumulative product changes to current submissions.
• Share knowledge with department and cross-functional teams.
• Provide solutions requiring evaluation and analysis.
• Prepare goals aligned with department plans and GMP guidelines.
• Write clear regulatory information for external agencies.
• Ensure compliance and effectiveness of the quality system.
• Advise on regulatory strategies for projects and groups.
• Coordinate submission-related activities for product approvals.

Skills

Teamwork

Communication

Regulatory knowledge

Problem solving

Ethical standards

Decision making

Education

Bachelor's degree or equivalent

Science background (biology, chemistry, etc.)

RAC certification (preferred)

Job description

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:

• 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, 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 RAC from the Regulatory Affairs Professionals Society.)
• Think analytically with good problem-solving skills.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is

$61,300.00 – $122,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota > St. Paul : 1225 Old Highway 8 NW

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf