Manager, Regulatory Compliance

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 109,000 colleagues serve people in more than 160 countries.

About Abbott

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

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

Our location in Westford, MA , currently has an opportunity for a Manager, Regulatory Compliance.

WHAT YOU'LL DO:

The Regulatory Compliance Manager is responsible for establishing an internal audit program to effectively assess and report on the business unit's compliance status relative to defined quality system requirements. Primary responsibilities include planning activities needed to assess the status of the quality system, organizing resources appropriate to execute the identified plan, approving documentation of the assessment results and corrective action taken, and reporting the status results to Management. The Regulatory Compliance Manager also supports the quality system by taking action to align activities with Divisional and Corporate Compliance objectives, by facilitating inspections with outside regulatory agencies, and by other tasks as assigned by Management.

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Recruits, coaches and develops organizational talent.;
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.;
  • Creates an entrepreneurial environment.;
  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.;
  • Keeps the organization's vision and values at the forefront of decision making and action.;
  • Demonstrates effective change leadership.;
  • Builds strategic partnerships to further departmental and organizational objectives.;
  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.;
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, EU MDR, PMDA regulations, etc.).;
  • Facilitates key quality processes at the site such as Inspection Readiness, Management Review, CAPA, and Training.;
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.;
  • Develops, monitors and appropriately adjusts the annual budget for department(s).;
  • Communicates to Management the compliance status of the business units quality system.;
  • Facilitates inspections of the business unit by outside Regulatory Agencies, including any required responses.


Supervisory / Management Responsibilities

Comments (optional)

(Supervision Received)

Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.;

(Supervision Provided)

Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; evaluates performance of and assists in career development planning for subordinates; often

responsible for a centralized staff or professional function of the company.

Position Accountability / Scope

(Influence/Leadership)

Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.;

(Planning/Organization)

Creates immediate to long-range plans to carry out objectives established by top management; develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.;

(Decision Making/Impact)

Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

EDUCATION AND EXPERIENCE YOU'LL BRING:

Minimum Education

Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.

Minimum Experience / Training Required

(Technical/Business Knowledge (Job Skills))

Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors company-wide indicators such as market share and profitability; monitors external environment in area of technical or professional responsibility. Will perform this job in a

quality system environment. Failure to adequately perform tasks can result in noncompliance with

governmental regulations.;

(Cognitive Skills)

Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups; facilitates others' participation in the continuous improvement program; investigates and solves problems that impact work processes and personnel within or across units or departments; develops and communicates a vision for the organizational unit assigned.

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:
  • A fast-paced work environment where your safety is our priority
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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 and @AbbottGlobal.

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