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 115,000 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\xe2\x80\x99ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the

student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s 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.

The Opportunity

This Regulatory Affairs Manager position is an onsite opportunity working out of our Austin, TX location in the Abbott Diabetes Care Division. This role will focus on providing leadership, coaching, and team management in relation to PMA / 510k submissions, and manufacturing projects for our FreeStyle Libre product family and next-generation products. We are seeking a Regulatory Affairs professional with experience in PMA or 510(k) submissions, change management for design and manufacturing process changes, people management, and collaborating with cross-functional teams, contract manufacturers, and suppliers.

What You\xe2\x80\x99ll Work On

Strategic Planning:

• Develop new regulatory policies, processes and SOPs and train key personnel on them
• Evaluate regulatory risks of division policies, processes, procedures
• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Identify emerging issues
• Monitor trade association positions for impact on company products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Recruit, develop and manage regulatory professionals

Pre-Market:

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile, prepare, review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies and update internal stakeholders
• Monitor applications under regulatory review
• Communicate application progress to internal stakeholders
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Manage and execute preapproval compliance activities

Post-Market:

• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
• Ensure compliance with product post-marketing approval requirements
• Ensure external communications meet regulations
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events
• Actively contribute to the development and functioning of the crisis/issue management program
• Analyze product-associated problems and develop proposals for solutions
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
• Report adverse events to regulatory agencies and internal stakeholders
• Provide regulatory input for product recalls and recall communications

Required Qualifications

• Bachelor\xe2\x80\x99s Degree or an equivalent combination of education and experience
• 4-5 years\xe2\x80\x99 experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.

Preferred Qualifications

• Bachelor\xe2\x80\x99s degree in Biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology math, engineering, or medical fields.
• Master\xe2\x80\x99s, MBA or PhD in a technical area or Law.
• 2-5 years of experience in regulatory but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Think analytically with good problem-solving skills.
• 510k submission experience.
• Experience managing and coaching a team.
• RAPS Certification.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

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 , on Facebook at and on Twitter @AbbottNews.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $90,700.00 \xe2\x80\x93 $181,300.00. In specific locations, the pay range may vary from the range posted.

Abbott