Regulatory Operations Compliance Project Manager Medical Devices (on-site)

JOB DESCRIPTION:

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. Youll 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 bachelors 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.

For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whether its glucose monitoring system innovative therapies for treating heart disease or products that help people with chronic pain or movement disorders our medical device technologies are designed to help people live their lives better and healthier. Every day our technologies help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine fingersticks.

The Opportunity

We are looking for a Regulatory Operations Compliance Project Manager to join our team on-site out of our Maple Grove or St. Paul MN locations. This Compliance Manager Global Regulatory Operations would be structured under Global Regulatory Services managing projects related to harmonized regulatory processes in Abbotts Medical Device Division. As an individual contributor the function of a Compliance Manager is to combine the knowledge of Regulatory Quality and Compliance to manage implementation of global emerging regulations and improve procedural compliance in response to Abbott Regulatory teams requests working closely with the international regulatory affiliates the medical device business unit RA teams and cross functional groups. The compliance projects require an experienced Regulatory mindset to lead complex cross functional/cross business strategic discussions and projects.

What Youll Work On

• Lead Regulatory process/procedure updates
• Implement emerging regulation requirements into Regulatory documentation with alignment with Abbott cross BU/ cross functional teams
• Develop and/or author new regulatory policies processes and SOPs
• Facilitate procedure implementation
• Provide strategic input and technical guidance on regulatory requirements for process decisions
• Evaluate regulatory risks of division policies processes procedures
• Develop and mentor regulatory professionals
• Drive change order activities
• Create supplemental training materials
• Review and follow document quality system structure
• Lead team meetings and document meeting minutes
• Work on process workflow development teams collaborating with Abbott IT system enhancement teams
• Author communications and presentations for upper management

Required Qualifications

• 2-5 years of experience in regulatory preferred but may consider quality assurance research and development/support scientific affairs operations or related area.
• Bachelors Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years experience in a regulated industry (e.g. medical products nutritionals).
• Ability to effectively communicate verbally and in writing prepare and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

• Familiarity with Regulatory Affairs departmental responsibilities and processes
• Familiarity of medical device regulatory requirements and submission/registration activities.
• Proven success managing multiple projects and priorities
• Domestic and international regulatory guidelines policies and regulations.
• Bachelors degree in science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields.
• Masters or Ph.D. in a technical area
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 5 years experience in a regulated industry
• CAPA experience
• Windchill experience
• Procedural Writing
• Regulatory Change Assessment
• International Product Registration support
• Ad and Promotional Material - Regulatory Review
• Project management skills organize and host meetings
• Quality System maintenance activities
• Documenting Justification for change from Regulatory perspective
• Regulatory history guidelines policies standards practicesrequirementsand precedents
• GDP

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.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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