Regulatory Affairs Specialist II Electrophysiology (on-site)
AbbottMinneapolis, MN, USjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionPreparation of regulatory submissions for Electrophysiology 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. 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. 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. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Regulatory Affairs Specialist II
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.
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.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, student debt program and 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
Required Qualifications
Preferred Qualifications
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives.
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.
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