Regulatory Affairs Manager, Advertising & Promotion - Medical Devices (Onsite) at Abbott Laboratories
Alameda, CA 94501
About the Job
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:
- 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.
The Opportunity
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
The function of a Regulatory Affairs Manager, Advertising & Promotion is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Responsible for providing regulatory guidance to shape and inform successful marketing campaigns and programs that range from traditional media to upcoming social media channels in established and emerging markets. This is a broad scoped position with strong opportunity for growth and career development based on performance.
Main Responsibilities
- Review advertising, promotional, corporate and other non-promotional materials for U.S. region to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
- Define regulatory advertising objectives to ensure campaigns are effective and appropriate for their intended audience.
- Liaise with managers in sales, marketing, and brand management to review campaigns that will help them achieve marketing and sales goals.
- Align with the organization's overall advertising and promotional strategy.
- Contribute to the review of marketing strategies for product, service, or market segment that align with the organization's vision and its current and long-term business objectives.
- Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Individual is recognized as a discipline expert and resource in regulatory affairs.
- Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
- Must have in-depth knowledge of commercial regulatory requirements associated with Advertising and Promotion of medical devices. Utilize technical regulatory skills to propose strategies on complex issues.
- Must be capable of developing and implementing regulatory strategy and working closely with various stakeholders. Evaluate risk of regulatory standards to product and safety issues on advertising and promotional materials and recommend solutions.
- Support RA Ad & Promo management ensuring on time department deliverables and developing mitigation plans for any issues that are identified, including Ad & Promo process improvements.
- May lead a cross-functional or cross-divisional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff developing their skills/abilities and assisting them in areas of efficiency and regulatory knowledge.
- Develop, communicate, and build consensus with various cross-functional depts (Marketing, Clinical/Scientific/Medical Affairs, Reimbursement, Legal & R&D) to be in alignment with the division and business goals. The role will require interfacing with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
- Creates immediate to long-range plans to carry out objectives established by top management. Assignments are expressed in the form of objectives. Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
- Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.
Experience and Qualifications
- Bachelor's Degree required preferably in engineering, science or a closely related discipline is desired.
- Master's Degree preferred in a technical area or M.B.A. is preferred.
- 4-5+ years of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired.
- Management/Leadership experience with direct reports preferred
- Have a broad knowledge of various technical regulatory alternatives and their potential impact on the business, in addition to exercising good and ethical judgment within policy and regulations.
- In-depth knowledge of business functions and cross group dependencies/relationships to define successful regulatory strategies.
- Prefer knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements, and precedents; Regulatory agency structure, processes, and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, advertising, and labeling.
- Domestic and international regulatory guidelines, policies and regulations a plus.
- Must be able to successfully handle multiple and competing priorities. Think analytically with good problem-solving skills. Organize and track complex information. Perform risk assessment or analysis.
- Certifications are a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Office programs skills to include Word, Excel, PowerPoint, Adobe Acrobat and SharePoint
* 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.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 $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.
