Medical Device Regulatory Affairs Development (RAD) Program (on-site)

Abbott Laboratories; California (MO); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Health coverage in HIP PPO next year

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Recognized as Great Place to Work

Job summary

Abbott Laboratories is offering a Medical Device Regulatory Affairs Development (RAD) Program with multiple rotation sites in CA, MN, TX, and more. The program includes three 1-year rotations performing regulatory documentation, submissions, and compliance tasks to support product entries.

You will interact with FDA and international agencies, manage regulatory tools, and contribute to QA/EMS initiatives to ensure timely market entry and ongoing compliance.

Qualifications

• Ability to work in a highly matrixed and geographically diverse environment.
• Ability to work in a team and as an individual contributor in a fast-paced setting.
• Strong written and verbal communications across levels of the organization.
• Multitasks, prioritizes, and meets deadlines with attention to detail.
• Maintains regular and predictable attendance and reliability.
• Willingness to relocate or move between US locations for rotations.

Responsibilities

• Prepare regulatory applications and annual reports to support registration objectives.
• Review and approve engineering changes and regulatory documentation.
• Interact with FDA and international agencies as directed.
• Maintain regulatory databases and global submission files for product releases.
• Support QMS, EMS, and other regulatory requirements across the enterprise.

Skills

Matrix environment

Team & individual contributor

Communication skills

Multitasking

Organizational skills

Attendance reliability

Travel readiness

Education

BA/BS in life sciences or engineering

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:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• - An excellent retirement savings plan with a high employer contribution
• - Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory business such as the regulatory database and global regulatory SharePoint sites.

What You’ll Work On

• - Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
• - Creates, reviews and approves engineering changes.
• - Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• - Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• - Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
• - Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• - May interface directly with FDA and other regulatory agencies if so directed.
• - Reviews protocols and reports to support regulatory submissions.
• - Support 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) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• - Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• - 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.
• - Ability to leverage and/or engage others to accomplish projects.
• - Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• - Multitasks, prioritizes and meets deadlines in timely manner.
• - Strong organizational and follow-up skills, as well as attention to detail.
• - Ability to maintain regular and predictable attendance.
• - Ability to move to various US locations based on rotational assignment

Preferred Qualifications

• - BA or BS degree in life sciences (i.e., chemistry, biology, etc.) or engineering (i.e., biomedical, mechanical, chemical, etc.). Recent graduates highly preferred.
• - Some experience with medical device industry.
• - Experience working in a broader enterprise/cross-division business unit model.

The base pay for this position is
$73,900.00 – $116,000.00
In specific locations, the pay range may vary from the range posted.

## JOB FAMILY:
Regulatory Operations

## DIVISION:
MD Medical Devices

## LOCATION:
United States > Santa Clara : Building A - SC

## ADDITIONAL LOCATIONS:
United States > Alameda : 2901 Harbor Bay Parkway, United States > Minnesota > Plymouth : 5050 Nathan Lane N, United States > Pleasanton : 6101 Stoneridge Dr, United States > Sylmar : 15900 Valley View Court, United States > Texas > Plano : 6901 Preston 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.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf