Senior Regulatory 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 Structural Heart (SH) Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps SH RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process.

Main Responsibilities

• Acts as SH RA representative for RA compliance related tasks in cross-functional team.

• Actively participates in all meetings and discussions and track assessment and implementation to completion

• Act as RA point of contact for current knowledge of global regulatory changes

• Review complex documents and literature for regulatory bodies to gain and maintain compliance

• Collaborate with cross-functional team to identify, assess and implement necessary regulatory changes

• Actively participate in all Global Regulatory Compliance team meetings and be prepared to summarize and communicate key highlights to the broader team, including project planning, documentation, task completion, updates, and issues requiring resolution.

• Perform regulatory product submissions for projects covering multiple product lines as needed.

• Assist team in IFU Competitive Analysis and Review Projects as needed

• Review Clinical documents and literature for RA as needed

• Supports all business segment initiatives as identified by divisional 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) and international regulations, 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.

• Provides mentoring and leadership to Regulatory Specialist I and II team members

Required Qualifications

• Bachelors Degree (± 16 years) in technical discipline highly preferred, OR an equivalent combination of education and work experience

• Minimum 5 years of technical experience, including at least 4 years of regulatory experience in the medical device industry.

• Experience with leading /collaborating with cross-functional teams to achieve project completion

• Proficient use of Microsoft Suite products (SharePoint experience is preferred)

• Experience in cross-collaboration within Global Regulatory environment

• Proven highly effective communication skills in all media and excellent interpersonal skills

• High attention to detail with excellent critical thinking skills

• Excellent follow through skills for reaching completion of tasks.

• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 5%, including internationally.

Preferred Qualifications

• 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