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

Thornton Tomasetti; Santa Clara (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Strong retirement plan

Tuition reimbursement

Education benefits

Global opportunities

Job summary

Abbott currently offers several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program, located in Alameda, Pleasanton, Santa Clara, CA, Minneapolis, MN or Plano, TX. The role entails three 1-year rotations, with regulatory documentation preparation, submissions, and global regulatory operations tasks.

You'll work to ensure compliance with FDA and worldwide regulations, while supporting product releases and regulatory strategies across multiple sites and teams.

Qualifications

• Bachelor's degree in life sciences or engineering; regulatory knowledge beneficial.
• Experience with regulatory submissions and FDA guidelines preferred.
• Ability to work in a highly matrixed, global environment.

Responsibilities

• Assist in preparing regulatory applications and annual reports.
• Review and approve engineering changes.
• Interface with FDA and other regulatory agencies as needed.
• Maintain regulatory databases and SharePoint sites for global submissions.

Skills

Regulatory affairs

FDA regulations

Regulatory submissions

Communication skills

Team collaboration

Education

BS in life sciences or engineering

Tools

Regulatory database

SharePoint

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

• 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 a 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 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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