- 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 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.
- Develops sound global regulatory strategies for new and modified medical devices.
- Lead author for FDA and European regulatory submissions
- Prepares robust regulatory applications to achieve departmental and organizational objectives.
- Creates, reviews and approves engineering changes.
- Reviews and understands medical device electrical safety test plans, software validations and cybersecurity measures.
- Provides leadership and guidance (including training) to other members of the RA staff.
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Provides Regulatory leadership to development teams:
- -Provides global strategic input (including all feasible alternatives and associated risks).
- -Drives cross functional alignment with issues that could have Regulatory ramifications.
- Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies).
- Builds strategic partnerships to further departmental and organizational objectives.
- Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Reviews protocols and reports to support regulatory submissions.
- Assesses proposed regulations and communicates new requirements to the organization.
- 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.
- Assists with audits and inspections, if required.
- Bachelor's degree OR an equivalent combination of education and work experience
- Minimum 6 years Regulatory experience
- Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
- 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 work independently with no oversight.
- Ability to identify and solve problems in a strategic manner.
- Ability to manage complex projects.
- Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.
- Bachelor's degree in a technical discipline
- 8 years Regulatory experience
- Experience working in a broader enterprise/cross-division business unit model
- Experience with IEC 60601 electrical safety testing, IEC 62304 medical device software, and medical device cybersecurity guidance.
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Regulatory Affairs Manager – Structural Heart - St. Paul, United States - Abbott Laboratories
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 114,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
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:
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
The Opportunity
We are recruiting for a Regulatory Affairs Manager to join our team on-site in our St. Paul, MN location. This individual contributor leads project submissions for FDA and EU regulatory approvals and acts independently to identify and resolve problems. This new team member applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of new product development programs in the transcatheter aortic valve product space which involves electrical/software components.
What You'll Work On
Required Qualifications
Preferred Qualifications
Apply Now
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 $95,000.00 – $190, In specific locations, the pay range may vary from the range posted.
