Medical Device Regulatory Affairs Rotations Program

Thornton Tomasetti; Santa Clara (CA); In loco; USD 74.000 - 116.000; Tempo pieno

Vantaggi offerti da questo lavoro

Free medical coverage (HIP PPO)

Strong retirement plan

Tuition reimbursement

Education benefits

Global opportunities

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory affairs

FDA regulations

Regulatory submissions

Communication skills

Team collaboration

Formazione

BS in life sciences or engineering

Strumenti

Regulatory database

SharePoint

Descrizione del lavoro

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.