Regulatory Affairs Specialist II – Electrophysiology (on-site)

AECOM; Plymouth (MN); On-site; USD 60,000 - 120,000; Full time

Job summary

Abbott is looking for a Regulatory Affairs Specialist II in Plymouth, MN. This key role focuses on ensuring compliance for medical devices, handling submissions, and collaborating with teams to support product release. The ideal candidate will thrive in a regulated environment and possess relevant experience.

Benefits

Career development opportunities

Free medical coverage

Tuition reimbursement

Excellent retirement savings plan

Qualifications

• 2-3 years’ experience in a regulated industry, preferably regulatory.
• Ability to work in a fast-paced, matrixed environment.

Responsibilities

• Preparation of regulatory submissions for medical devices.
• Review and approve engineering change orders for protocols.

Skills

Strong verbal and written communication

Team collaboration

Education

Bachelor’s degree (or equivalent)

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

Master’s degree in Regulatory Affairs

Job description

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 114,000 colleagues serve people in more than 160 countries.

**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, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-stude...) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree...) 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.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

**The Opportunity**

Abbott is seeking a passionate, experienced **Regulatory Affairs Specialist II** to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

**What You’ll Work On**

+ Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives.

+ Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.

+ Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.

+ Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.

+ Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.

+ Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.

+ May interface directly with FDA and other regulatory agencies if so directed.

+ Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

+ Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

+ Performs other related duties and responsibilities as assigned.

**Required Qualifications**

+ Bachelor’s degree (or equivalent)

+ 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.

**Preferred** **Qualifications**

+ Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.

+ Master’s degree in Regulatory Affairs.

+ Regulatory experience with capital equipment including software, firmware, graphical user interfaces, and associated hardware.

Apply Now (https://www.jobs.abbott/us/en)

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [e-mail]