Abbott
Regulatory Affairs Specialist II - Ventures (on-site)
Abbott - Saint Paul, Minnesota, United States, 55199
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Overview
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
Join to apply for the
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
role at
Abbott Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
Join to apply for the
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
role at
Abbott 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
This
Regulatory Affairs Specialist II
will work on-site at our Santa Clara, CA or Woodridge, MN location in our Abbott Ventures division to perform regulatory activities for a transcatheter heart valve replacement device.
The Opportunity
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry.
What You’ll Work On
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. May interface directly with FDA and other regulatory agencies. Supports the product release process by creating GTS licenses or reviewing and approving requests for product release. Reviews protocols and reports to support regulatory submissions. 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.
Required Qualifications
Bachelor’s Degree or an equivalent combination of education and work experience Minimum 3 years’ related experience, including a minimum of two years regulatory experience Experience with either 510(k) applications, IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects. Strong problem-solving skills and ability to think strategically and see the big picture. Adaptable with the ability to switch priorities and accomplish all tasks. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Strong organizational and follow-up skills, as well as attention to detail. Multitasks, prioritizes and meets deadlines in timely manner.
Preferred Qualifications
Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics). Master’s degree Experience with regulatory activities required for clinical trials. Experience working in a broader enterprise/cross-division business unit model. Experience working in the Medical Device industry. Regulatory Affairs Professionals Society Certification is a plus.
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 $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted. Seniority level
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Join to apply for the
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
role at
Abbott Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
Join to apply for the
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
role at
Abbott 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
This
Regulatory Affairs Specialist II
will work on-site at our Santa Clara, CA or Woodridge, MN location in our Abbott Ventures division to perform regulatory activities for a transcatheter heart valve replacement device.
The Opportunity
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry.
What You’ll Work On
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. May interface directly with FDA and other regulatory agencies. Supports the product release process by creating GTS licenses or reviewing and approving requests for product release. Reviews protocols and reports to support regulatory submissions. 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.
Required Qualifications
Bachelor’s Degree or an equivalent combination of education and work experience Minimum 3 years’ related experience, including a minimum of two years regulatory experience Experience with either 510(k) applications, IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects. Strong problem-solving skills and ability to think strategically and see the big picture. Adaptable with the ability to switch priorities and accomplish all tasks. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Strong organizational and follow-up skills, as well as attention to detail. Multitasks, prioritizes and meets deadlines in timely manner.
Preferred Qualifications
Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics). Master’s degree Experience with regulatory activities required for clinical trials. Experience working in a broader enterprise/cross-division business unit model. Experience working in the Medical Device industry. Regulatory Affairs Professionals Society Certification is a plus.
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 $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Abbott by 2x Get notified about new Regulatory Affairs Specialist jobs in
Santa Clara, CA . Union City, CA $100,000.00-$120,000.00 3 weeks ago Regulatory Affairs Specialist - (NMPA/CFDA)
Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Sunnyvale, CA $97,600.00-$165,200.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)
Regulatory Affairs Assoc II CMC - Small Molecules
San Jose, CA $172,000.00-$234,000.00 2 days ago Milpitas, CA $115,000.00-$150,000.00 2 weeks ago Sunnyvale, CA $80,000.00-$140,000.00 1 week ago Sunnyvale, CA $118,000.00-$172,000.00 2 weeks ago Union City, CA $130,000.00-$155,000.00 6 days ago Menlo Park, CA $118,000.00-$172,000.00 2 weeks ago Senior Regulatory Affairs Specialist -Vascular (on-site)
Regulatory Affairs / Admin in Sunnyvale, CA 94043 (Hybrid - 3 Days Onsite)
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
San Francisco Bay Area $60.00-$63.00 2 weeks ago Regulatory Affairs Compliance Specialist - Pleasanton, CA
Pleasanton, CA $115,000.00-$125,000.00 2 weeks ago Sr Regulatory Affairs Specialist - Shockwave Medical
Union City, CA $100,000.00-$120,000.00 3 weeks ago Senior Regulatory Affairs Specialist – Vascular (on-site)
Associate Director, Regulatory Affairs - Global Labeling
Foster City, CA $165,495.00-$235,620.00 3 days ago Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
Sunnyvale, CA $119,900.00-$203,000.00 2 days ago Global Privacy Counsel, Regulatory Investigations
San Jose, CA $140,000.00-$240,000.00 4 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr