Medical Device Regulatory Affairs Rotational Program

Abbott Laboratories; Plano (TX); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Retirement savings plan

Tuition reimbursement

Job summary

Abbott is offering a Medical Device Regulatory Affairs Development (RAD) Program with three 1-year rotations across US sites, including Plano, TX. You will prepare regulatory submissions, review engineering changes, and ensure compliance with FDA and global regulations.

The role may involve regulatory operations tasks and interactions with regulators. The program targets candidates with life sciences or engineering backgrounds, strong communication, and teamwork skills, ready to relocate as

Qualifications

• Work in a matrixed, geographically diverse environment.
• Collaborate in a team and as an individual contributor in a fast-paced setting.
• Leverage others to accomplish projects.
• Strong verbal and written communication at multiple levels in the organization.
• Multitask, prioritize and meet deadlines.
• Strong organizational and follow-up skills with attention to detail.
• Maintain regular attendance.
• Willingness to move to various US locations based on rotations.

Responsibilities

• Assist in regulatory applications preparation (including annual reports).
• Create, review and approve engineering changes.
• Act as regulatory representative for applicable guidelines.
• Review communications to ensure regulatory standards (FDA and worldwide) are met.
• Maintain domestic and international medical device regulations in submission databases.
• Support product release processes by creating licenses or reviewing release requests.
• Interface with FDA and other regulatory agencies as needed.
• Review protocols and reports to support submissions.
• Support QMS/EMS and other regulatory requirements.
• Ensure compliance with FDA and other regulations and maintain cross-functional communications.

Skills

Regulatory affairs

Communication

Teamwork

Multitasking

Time management

Attention to detail

Attendance reliability

Education

Life sciences degree

Engineering degree

Job description

Abbott is offering a Medical Device Regulatory Affairs Development (RAD) Program with three 1-year rotations across US sites, including Plano, TX. You will prepare regulatory submissions, review engineering changes, and ensure compliance with FDA and global regulations.

The role may involve regulatory operations tasks and interactions with regulators. The program targets candidates with life sciences or engineering backgrounds, strong communication, and teamwork skills, ready to relocate as