Overview In this role you drive regulatory strategy and submissions to enable global product registrations. You will partner with cross-functional teams to support development, lifecycle management, and market access for Abbott's medical products. You will manage regulatory submissions, liaise with authorities, and ensure compliant communications and documentation. The role combines scientific, regulatory, and business issues to keep products compliant across regions. You will lead with integrity, shaping regulatory pathways and contributing to the company's mission to improve patient lives.
Compensation / Benefits- free medical coverage in HIP PPO plan
- high employer contribution to retirement plan
- tuition reimbursement and education benefits
- opportunity for career development in an international company
- recognition as a great place to work and diverse opportunities
Responsibilities- Develop and execute global regulatory strategies supporting development, registration, commercialization, and lifecycle management
- Provide regulatory guidance on product development, manufacturing changes, and post-market activities
- Assess regulatory risks and recommend strategies to support business objectives and market access
- Support regulatory due diligence for acquisitions and partnerships
- Lead preparation, review, and submission of regulatory filings to global health authorities
- Manage agency reviews, coordinate responses to inquiries, and serve as primary regulatory contact
- Support regulatory pathways (FDA, EU MDR/CE Mark, SaMD) and other global routes
- Ensure compliance with regulatory requirements (FDA, EU MDR, ISO 13485) and manage registrations and post-market obligations
- Review labeling and promotional materials for compliance
- Oversee adverse event reporting, field actions, recalls, and product safety activities
- Collaborate with Quality to improve the Quality Management System and regulatory processes
- Mentor Regulatory Affairs staff and lead cross-functional regulatory projects
- Promote a culture of compliance, collaboration, and continuous improvement
Key requirements- Bachelor's Degree in a related field or equivalent experience
- 9 years of related work experience
- Experience within a QMS with product lifecycle understanding
- Ability to interpret and apply domestic and international regulatory guidelines
- Experience guiding global regulatory strategies for new submissions or complex changes
- Assessing regulatory impacts of labeling, manufacturing, and design changes for PMA, 510(k), and EU MDR
- Authoring PMA/IDE supplements, Submissions, 510(k)s, EU changes
- Experience mentoring staff and leading regulatory projects
- Experience with regulators and Notified Bodies (FDA, BSI, etc.) and international regulatory requirements
- effective communicator
- cross-functional collaboration
- mentoring and leadership
- Regulatory submissions (PMA, IDE, 510(k), EU MDR changes)
- Regulatory strategy development
- FDA and EU regulatory requirements for medical devices
