Abbott Laboratories
Senior Regulatory Affairs Specialist – Cardiac Rhythm Management (on-site)
Abbott Laboratories, Los Angeles, California, United States, 90079
Senior Regulatory Affairs Specialist – Cardiac Rhythm Management (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.JOB DESCRIPTION:
Working at AbbottAt 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.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.As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.The OpportunityOur location in Sylmar, CA currently has an on-site opportunity for a
Senior Regulatory Affairs Specialist
with our Cardiac Rhythm Management division. This position leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. This new team member provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.What You’ll Work OnPrepares robust regulatory applications to achieve departmental and organizational objectives.Creates, reviews, and approves change orders.Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.Acts as a liaison between the Company and various regulatory agencies, ensuring that communications are specific and convey all necessary detail.Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations.Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.Interfaces directly with FDA and other regulatory agencies.Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.Conducts reviews of product and manufacturing changes for compliance with applicable regulations.Reviews protocols and reports to support regulatory submissions.Supports all business segment initiatives as identified by divisional management.Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, and Company policies.Provides mentoring and leadership to Regulatory Specialist I and II team members.Required QualificationsBachelor's degree or an equivalent combination of education and work experience.Minimum 3 years’ experience in a regulated industry (e.g., medical products, nutritionals).Experience with submission/registration types and requirements.Strong verbal and written communications.Multitasks, prioritizes, and meets deadlines in a timely manner.Strong organizational and follow-up skills.Preferred QualificationsMaster’s Degree in Regulatory Affairs.Experience with either 510(k) applications, PMA supplements, or EU and other international medical device regulations.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.Experience working in the Medical Device industry.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Apply NowThe base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
CRM Cardiac Rhythm ManagementLOCATION:
United States > Sylmar : 15900 Valley View CourtWORK SHIFT:
StandardTRAVEL:
Yes, 5 % of the TimeMEDICAL SURVEILLANCE:
NoSIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive movements, Continuous sitting for prolonged periods.Abbott is an Equal Opportunity Employer, committed to employee diversity.
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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.JOB DESCRIPTION:
Working at AbbottAt 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.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.As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.The OpportunityOur location in Sylmar, CA currently has an on-site opportunity for a
Senior Regulatory Affairs Specialist
with our Cardiac Rhythm Management division. This position leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. This new team member provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.What You’ll Work OnPrepares robust regulatory applications to achieve departmental and organizational objectives.Creates, reviews, and approves change orders.Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.Acts as a liaison between the Company and various regulatory agencies, ensuring that communications are specific and convey all necessary detail.Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations.Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.Interfaces directly with FDA and other regulatory agencies.Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.Conducts reviews of product and manufacturing changes for compliance with applicable regulations.Reviews protocols and reports to support regulatory submissions.Supports all business segment initiatives as identified by divisional management.Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, and Company policies.Provides mentoring and leadership to Regulatory Specialist I and II team members.Required QualificationsBachelor's degree or an equivalent combination of education and work experience.Minimum 3 years’ experience in a regulated industry (e.g., medical products, nutritionals).Experience with submission/registration types and requirements.Strong verbal and written communications.Multitasks, prioritizes, and meets deadlines in a timely manner.Strong organizational and follow-up skills.Preferred QualificationsMaster’s Degree in Regulatory Affairs.Experience with either 510(k) applications, PMA supplements, or EU and other international medical device regulations.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.Experience working in the Medical Device industry.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Apply NowThe base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Regulatory OperationsDIVISION:
CRM Cardiac Rhythm ManagementLOCATION:
United States > Sylmar : 15900 Valley View CourtWORK SHIFT:
StandardTRAVEL:
Yes, 5 % of the TimeMEDICAL SURVEILLANCE:
NoSIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive movements, Continuous sitting for prolonged periods.Abbott is an Equal Opportunity Employer, committed to employee diversity.
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