Heart Failure Regulatory Affairs Lead | Submissions & Strategy

Regulatory Jobs; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

HIP PPO medical plan

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Great place to work

Job summary

Abbott in Pleasanton, CA is seeking a Regulatory Affairs Manager in the Heart Failure division to ensure device registrations meet US and international requirements on-site. You will lead submissions, assess regulatory risk, and guide cross-functional teams to support product registrations.

Role emphasizes strategic regulatory planning, mentorship, and communicating plans to senior leaders within a matrixed organization.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent
• Minimum 6 years regulatory experience
• Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or EU and other international medical device regulations
• 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 work independently with no oversight
• Ability to identify and solve problems in a strategic manner
• Ability to manage complex projects
• Ability to be proactive and not reactive, to anticipate changing business and regulatory environments

Responsibilities

• Lead regulatory submissions and coordinate cross-functional teams
• Define regulatory strategy and ensure compliance for registrations
• Collaborate with diverse teams and communicate plans to senior leadership
• Ensure data needs are identified, gathered, and presented for submissions

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Verbal and written communication

Multi-tasking

Organizational skills

Problem-solving

Independent work

Project management

Proactive mindset

Education

Bachelor’s degree in a technical discipline

Advanced degree

Bachelor’s degree in science (biology, chemistry, immunology, medical tech, pharmacy, pharmacology)

Job description

Abbott in Pleasanton, CA is seeking a Regulatory Affairs Manager in the Heart Failure division to ensure device registrations meet US and international requirements on-site. You will lead submissions, assess regulatory risk, and guide cross-functional teams to support product registrations.

Role emphasizes strategic regulatory planning, mentorship, and communicating plans to senior leaders within a matrixed organization.