Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries
Requirements
- Bachelor’s degree
Responsibilities
- Preparation 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
- Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines
- Review and evaluate 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
- Maintain 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
- Ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested
- Support 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
- Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Perform other related duties and responsibilities as assigned
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Abbott offer?
Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.
Is this position remote or on-site?
This is an on-site position in Plymouth, MN.
What are the main responsibilities of this role?
The role involves preparation of regulatory submissions for Electrophysiology devices, review and approval of engineering change orders, acting as a regulatory representative for guideline analysis, reviewing communications for regulatory standards, and maintaining domestic and international medical device regulations.
What is Abbott's company culture like?
Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.
What makes a strong candidate for this Regulatory Affairs Specialist II role?
A strong candidate is passionate and experienced in regulatory affairs, particularly with Electrophysiology devices, capable of performing specialized analyses, preparing submissions, reviewing engineering changes, analyzing regulatory guidelines, and maintaining up-to-date knowledge of domestic and international medical device regulations.
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees