Associate Director Regulatory Affairs – Vascular

Regulatory Jobs; Westford (MA); On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Freeeducation benefit

Job summary

Abbott is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and submissions for vascular products. This on-site role at our Westford, MA location requires directing a team of regulatory professionals and interfacing with FDA and international agencies to ensure timely approvals.

The position emphasizes governance of regulatory data, development of guidance for product development teams, and ongoing liaison with senior management on regulatory plans.

Qualifications

• Bachelor’s degree or equivalent required.
• 5–7 years’ experience in a regulated industry (e.g., medical products).
• Experience in regulatory preferred but may consider related areas.

Responsibilities

• Sets strategy and directs submissions for products to regulatory agencies.
• Guides regulatory requirements and strategies to product development teams.
• Maintains knowledge of laws, regulations and enforcement decisions affecting operations.
• Directs staff in implementing regulatory strategy and preparing submissions.
• Interacts with outside regulatory agencies and provides executive metrics.

Skills

Regulatory affairs

Leadership

Regulatory strategy

Regulatory submissions

Education

Bachelor’s degree

MS or MBA preferred

Job description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for 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 Opportunity

This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate Director, Regulatory Affairs 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 will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will ensure that data is identified, obtained and effectively presented for the registration of products worldwide.

What You’ll Work On

• Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
• Provides guidance on regulatory requirements and strategies to product development project teams.
• Provides regulatory input for capital equipment and software, including knowledge of IEC standards (e.g., IEC 60601-1)
• Provides regulatory input on cybersecurity and Artificial Intelligence (AI)
• Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
• Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals.
• Directs staff in implementing regulatory strategy and preparing regulatory submissions.
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Performs related functions and responsibilities, on occasion, as assigned.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Supports all Company initiatives as identified by 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 communication.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience
• 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 5-7 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with 510k / PMA submissions
• Experience working with hardware/ software devices
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices

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.

The base pay for this position is

$129,300.00 – $258,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

AVD Vascular

LOCATION:

United States > Massachusetts > Westford : 4 Robbins Road

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % 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)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf