Regulatory Affairs Intelligence Specialist

Working at Abbott

• At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.

WHAT YOU’LL DO

Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in St. Paul, MN.

This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, the Regulatory Affairs Intelligence Specialist:

• Monitors and fact-checks new or changing global regulations

• Tracks and documents regulations within the regulatory intelligence systems

• Supports the communication of emerging regulations, documents for comment, and regulations in implementation

• Performs regulatory investigations to assess medical device regulatory changes within a specific country or region

• Supports the maintenance of, or continuous improvement of quality system procedures, and documents

• May train others on systems and processes

• Facilitates the collection and reporting of data in support of key performance indicators

• Gathers additional data to support interpretation, and aid businesses in determining impact

• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements

• Complies with 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, etc.

• Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications

• Bachelors Degree (± 2 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience

• Minimum 2 years This position does not require previous regulatory 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.

• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.

• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.

• Work with cross-functional teams. Work with people from various disciplines and cultures.

• Write and edit technical documents.

• Negotiate internally.

• Pay strong attention to detail.

• Manage projects. Create project plans and timelines.

• Think analytically and critically.

• Organize and track complex information.

• 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.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.

Preferred Qualifications

• 2-4+ years’ experience in medical devices, or a regulated industry (e.g., nutritional, pharma) preferred. Experience in a Regulatory or Quality role, a plus.

• Ability to work within a fast-paced and matrixed team environment

• Strong verbal and written communication skills · Strong attention to detail and organizational skills

• Proficient in Excel, and all programs with MS Office suite (Word, PowerPoint, Outlook)

• Experience in program management a plus

• Experience with document management systems a plus