Regulatory Affairs Job at Abbott | Apply Now
Regulatory affairs job opportunities at Abbott offer an exciting pathway for life sciences graduates to build a strong career in the medical device industry. This Medical Device Regulatory Affairs Development (RAD) Program in the United States is designed to provide hands-on experience through rotational assignments, helping candidates gain expertise in regulatory submissions, compliance, and global product approvals. If you are looking for Abbott careers or life sciences jobs in the US, this opportunity is worth exploring.
- Job Position: Medical Device Regulatory Affairs Development (RAD) Program
- Location: United States, including Alameda, Pleasanton, and Santa Clara (CA), Minneapolis (MN), and Plano (TX)
About the Company
Regulatory affairs job opportunities at Abbott are part of a global healthcare leader that helps people live more fully at all stages of life. Abbott’s portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 115,000 employees serving people in more than 160 countries, Abbott careers provide a strong platform for professionals seeking life sciences jobs in the US.
Job Description
Regulatory affairs job in the Medical Device Regulatory Affairs Development (RAD) Program involves three 1-year rotations with specialized assignments in regulatory submissions, compliance, and product registration. The role includes evaluation, preparation, and submission of documentation to ensure products meet regulatory agency specifications. It also supports regulatory activities required for product market entry and may include regulatory operations such as global product release logistics and maintaining regulatory databases.
Qualifications
Required
Regulatory affairs job candidates must demonstrate the ability to work in a matrixed and geographically diverse environment.
- Strong verbal and written communication skills
- Ability to multitask, prioritize, and meet deadlines
- Strong organizational and attention to detail skills
- Ability to work independently and in teams
- Willingness to relocate within the US for rotational assignments
Preferred
Regulatory affairs job applicants with a background in life sciences or engineering are preferred.
- BA or BS degree in life sciences (biology, etc.)
- Experience in the medical device industry
- Experience working in cross-functional or enterprise environments
Key Responsibilities
Regulatory affairs job responsibilities include assisting in the preparation of regulatory applications, including annual reports, to meet organizational objectives.
- Create, review, and approve engineering changes
- Act as a regulatory representative for reviewing guidelines
- Review communications to ensure compliance with FDA and global standards
- Maintain domestic and international medical device regulations
- Support product release processes and regulatory documentation
- Interface with FDA and other regulatory agencies when required
- Review protocols and reports for regulatory submissions
- Support Quality Management Systems (QMS) and Environmental Management Systems (EMS)
- Ensure compliance with FDA regulations and company policies
- Collaborate with cross-functional teams and stakeholders
