Abbott
Regulatory Affairs Manager - Advertising & Promotions - Vascular
Abbott, Santa Clara, California, us, 95053
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 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 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 Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, and peripheral stents. The
Regulatory Affairs Manager, Advertising & Promotions
is responsible for championing the compliance effort in the review and approval of advertising & promotional materials for product, disease state, and training/education programs. WHAT YOU’LL DO: Timely review of all advertising & promotional/non-promotional materials to ensure compliance with the terms of approved product registrations, applicable laws, internal policies, and external regulations. Ensure all advertising & promotional materials are (i) accurate, truthful, and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures. Maintain current knowledge of the applicable regulatory requirements and assess potential risk and impact to the advertising & promotional processes. Continually assess advertising & promotion-related processes and procedures to enhance efficiencies and effectiveness and recommend/implement policy and/or process changes as needed. Work independently and recognize when issues need to be elevated to Management. Develop/implement advertising & promotion-related strategy to maintain/improve Quality System and Regulatory compliance. Contribute to audit and CAPA (Corrective and Preventive Action) activities to maintain effectiveness of the advertising & promotion process. Contribute to the review of advertising & promotion strategies for a product, service, or market segment that aligns with the organization’s vision and its current and long-term business objectives. Has department/group level influence and is generally recognized as an expert resource within the department; share knowledge and expertise with others in support of team activities. Develop, communicate, influence, and build consensus with various cross-functional departments (e.g. Marketing, Scientific/Clinical/Medical Affairs, Legal & R&D [Research & Development]) to be in alignment with the division and business goals. Required Qualifications: Bachelor’s Degree or an equivalent combination of education and experience 4-5 years’ experience in a regulated industry (e.g., medical devices). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. In-depth knowledge of regulatory requirements associated with advertising and promotion of medical device products. Preferred Qualifications: Bachelor’s degree in science, biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical fields Advanced degree helpful Minimum of 2(+) years in medical device Ad/Promo (Advertising / Promotions) regulatory experience Knowledge of domestic and international regulatory history, guidelines, policies, standards, practices, requirements and precedents. Principles and requirements of applicable product laws. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Communicate effectively verbally and in writing. Strong attention to detail Must be able to juggle multiple and competing priorities. Think analytically with good problem-solving skills. Exercises good and ethical judgment within policy and regulations. 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:
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. The base pay for this position is
$109,300.00 – $218,500.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations DIVISION:
AVD Vascular LOCATION:
United States > Santa Clara : Building B - SC ADDITIONAL LOCATIONS:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW WORK SHIFT:
Standard TRAVEL:
Yes, 5 % of the Time MEDICAL SURVEILLANCE:
No SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
#J-18808-Ljbffr
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 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 Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, and peripheral stents. The
Regulatory Affairs Manager, Advertising & Promotions
is responsible for championing the compliance effort in the review and approval of advertising & promotional materials for product, disease state, and training/education programs. WHAT YOU’LL DO: Timely review of all advertising & promotional/non-promotional materials to ensure compliance with the terms of approved product registrations, applicable laws, internal policies, and external regulations. Ensure all advertising & promotional materials are (i) accurate, truthful, and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures. Maintain current knowledge of the applicable regulatory requirements and assess potential risk and impact to the advertising & promotional processes. Continually assess advertising & promotion-related processes and procedures to enhance efficiencies and effectiveness and recommend/implement policy and/or process changes as needed. Work independently and recognize when issues need to be elevated to Management. Develop/implement advertising & promotion-related strategy to maintain/improve Quality System and Regulatory compliance. Contribute to audit and CAPA (Corrective and Preventive Action) activities to maintain effectiveness of the advertising & promotion process. Contribute to the review of advertising & promotion strategies for a product, service, or market segment that aligns with the organization’s vision and its current and long-term business objectives. Has department/group level influence and is generally recognized as an expert resource within the department; share knowledge and expertise with others in support of team activities. Develop, communicate, influence, and build consensus with various cross-functional departments (e.g. Marketing, Scientific/Clinical/Medical Affairs, Legal & R&D [Research & Development]) to be in alignment with the division and business goals. Required Qualifications: Bachelor’s Degree or an equivalent combination of education and experience 4-5 years’ experience in a regulated industry (e.g., medical devices). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. In-depth knowledge of regulatory requirements associated with advertising and promotion of medical device products. Preferred Qualifications: Bachelor’s degree in science, biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical fields Advanced degree helpful Minimum of 2(+) years in medical device Ad/Promo (Advertising / Promotions) regulatory experience Knowledge of domestic and international regulatory history, guidelines, policies, standards, practices, requirements and precedents. Principles and requirements of applicable product laws. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Communicate effectively verbally and in writing. Strong attention to detail Must be able to juggle multiple and competing priorities. Think analytically with good problem-solving skills. Exercises good and ethical judgment within policy and regulations. 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:
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. The base pay for this position is
$109,300.00 – $218,500.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Regulatory Operations DIVISION:
AVD Vascular LOCATION:
United States > Santa Clara : Building B - SC ADDITIONAL LOCATIONS:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW WORK SHIFT:
Standard TRAVEL:
Yes, 5 % of the Time MEDICAL SURVEILLANCE:
No SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
#J-18808-Ljbffr