Medical Device Regulatory Affairs RAD Program – Rotational

Regulatory Jobs; Santa Clara (CA); Presencial; USD 74.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

HIP PPO medical plan

Excellent retirement savings plan

Tuition reimbursement

Free U education benefit

Descripción de la vacante

Abbott is offering a Medical Device Regulatory Affairs Development (RAD) program with three 1-year rotations across regulatory submissions, documentation, and operations. Positions will be based in Alameda, Pleasanton, Santa Clara, CA, with additional sites in MN and TX.

Rotations may involve regulatory activities and global database maintenance. Candidates should have a life sciences or engineering background, strong communication skills, and adaptability to a matrixed work environment.

Formación

• Strong communication and written skills across levels in the organization.
• Ability to work in a matrixed, global environment.
• Ability to multitask and meet deadlines in a fast-paced setting.
• Familiarity with regulatory guidelines and FDA/global standards.

Responsabilidades

• Assist in preparing regulatory applications and annual reports.
• Review and approve engineering changes.
• Act as regulatory representative on guidelines analysis.
• Review communications for regulatory compliance and completeness.
• Maintain up-to-date domestic and international medical device regulations.
• Support product release through licensing and approvals.
• Interface with FDA and other agencies as needed.
• Support QMS, EMS, and other regulatory requirements.

Conocimientos

Strong communication

Teamwork

Attention to detail

Regulatory knowledge

Educación

Bachelor's degree in life sciences or engineering

Descripción del empleo

Abbott is offering a Medical Device Regulatory Affairs Development (RAD) program with three 1-year rotations across regulatory submissions, documentation, and operations. Positions will be based in Alameda, Pleasanton, Santa Clara, CA, with additional sites in MN and TX.

Rotations may involve regulatory activities and global database maintenance. Candidates should have a life sciences or engineering background, strong communication skills, and adaptability to a matrixed work environment.