Regulatory Affairs Project Manager – Vascular (on-site)

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.

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’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 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 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
  
  

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

The Opportunity

This Regulatory Affairs Project Manager position is an onsite opportunity working out of our St. Paul, MN location in the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Additionally, will coordinate preparation of well organized, complete and scientifically sound regulatory submissions as well as interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications. This new team member will exercise judgement within generally defined practices and departmental standard operating procedures and develop and maintain strong and effective relations with internal/external personnel.

What You’ll Work On

• Demonstrate excellent project management skills to plan for, lead and author regulatory submissions in key markets (including US and EU) for new, complex products.
• Work with Regulatory leadership to prepare global regulatory plan/strategy for product introductions, determine submission and approval requirements for global registrations.
• Represent the Regulatory function on product development teams to provide strategic input to product lifecycle planning; anticipate regulatory obstacles and emerging issues throughout lifecycle.
• Apply technical regulatory skills and expertise to propose solutions on complex issues.
• Negotiate and interact with regulatory authorities during product development and submission review to deliver on predictable submission approvals.
• Ensure that submissions are of high-quality and are complete, properly formatted, and comply with applicable regulatory requirements.
• Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale.
• Ensure that submissions are of high-quality and are complete, properly formatted, and comply with applicable regulatory requirements.
• Provide input and comment on regulations and standards which may affect Division products.
• Review and make recommendations on policies and procedures that impact regulatory activities.
• Provide mentorship to other RA staff in department.
• Accountable for communication to cross-functional partners, internal and external stakeholders, and Regulatory leadership.
  
  

Required Qualifications

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 3 years related regulatory affairs experience including oversight of submissions for new products and product changes in the health care industry and/or medical devices industry plus at least 1 year in an RA project management role. Some of the required 3 years overall RA experience can be substituted with experience in a scientific/technical role in the health care industry and/or medical devices industry.
• Must have well developed written, oral, interpersonal and negotiation skills.
• Leadership competency including organizational development and project management skills.
  
  

Preferred Qualifications

• Bachelor's degree in a scientific or engineering related discipline.
• Advanced degree or additional professional training in regulatory affairs (RA) desired.
• Previous experience with PMA / IDE submissions
• Experience with Class III medical devices
• Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Ability to work effectively on cross-functional teams
• Strong attention to detail and project management skills
• Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
  
  

Apply Now

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

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.