Regulatory Affairs Specialist II
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What you'll do
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software
- Strategic Planning: Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review and submit regulatory submission to authorities to support both investigational and commercial approval.
- Utilize technical regulatory skills to propose strategies on complex issues
- Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports 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.
- Postmarket: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product postmarketing approval requirements.
- Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.
What they're looking for
- Bachelor’s Degree or an equivalent combination of education and experience
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred 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.
- Ability to work in a highly matrixed and geographically diverse environment.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Exercise good and ethical judgment within policy and regulations.
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
- Define regulatory strategy with supervision.
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
Nice to have
- Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
- 3 - 5 years of regulatory experience.
- Knowledge of software and electrical regulations.
- Ability to think analytically and have good problem-solving skills.
- PMA or investigational device regulatory submission experience.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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. 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
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 Specialist to join our team on-site in New Brighton, MN. This new team member will be overseeing our innovating Transcatheter Aortic Valve Implantation Franchise within the Abbott Structural Heart Franchise.
As an individual contributor, the Regulatory Affairs Specialist will support product development activities to ensure both investigation and commercial regulatory approvals are achieved. In this role, you will provide regulatory input on design and development activities to cross functional teams including software development. Additionally, provide submission authoring and compilation to meet program objectives and timelines.
What You’ll Work On
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software
- Strategic Planning: Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review and submit regulatory submission to authorities to support both investigational and commercial approval.
- Utilize technical regulatory skills to propose strategies on complex issues
- Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports 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.
- Postmarket: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product postmarketing approval requirements.
- Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and experience
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred 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.
- Ability to work in a highly matrixed and geographically diverse environment.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Exercise good and ethical judgment within policy and regulations.
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
- Define regulatory strategy with supervision.
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
Preferred Qualifications
- Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
- 3 - 5 years of regulatory experience.
- Knowledge of software and electrical regulations.
- Ability to think analytically and have good problem-solving skills.
- PMA or investigational device regulatory submission experience.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
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
$61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
SH Structural Heart
LOCATION:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Company
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