Principal Regulatory Affairs Specialist (Business Partnerships).

📌 Core Information

🔹 Job Title: Principal Regulatory Affairs Specialist (Business Partnerships)

🔹 Company: Abbott

🔹 Location: Alameda, California, United States

🔹 Job Type: On-site

🔹 Category: Not specified

🔹 Date Posted: April 2, 2025

🔹 Experience Level: 5-10 years

🔹 Remote Status: On-site

📌 Essential Job Details

🚀 Job Overview

Key aspects of this role include:

• Developing global regulatory strategies for product lifecycle management
• Driving regulatory compliance and strategy for new business partnerships
• Interfacing with external regulatory agencies and trade associations
• Influencing and monitoring changing regulations and guidance

ASSUMPTION: The focus on business partnerships suggests collaboration with external entities to enhance diabetes management solutions.

📋 Key Responsibilities

✅ Develop global regulatory strategies for product development and lifecycle management.

✅ Analyze and align regulatory outcomes with product concepts, recommending future actions.

✅ Provide technical leadership and strategic input on complex issues to business units.

✅ Anticipate regulatory obstacles; develop solutions with cross-functional teams.

✅ Create and manage project plans, timelines, and regulatory submissions.

✅ Administer regulatory requirements, ensuring compliance with labeling and post-marketing.

✅ Monitor and address emerging regulatory issues and assess corporate policy risks.

✅ Oversee partnership regulatory activities, ensuring compliance and process improvements.

✅ Develop and manage crisis/issue management programs related to regulatory affairs.

ASSUMPTION: Responsibilities imply a senior role with comprehensive oversight expected to influence strategic decisions.

🎯 Required Qualifications

Education: Bachelor’s Degree in a scientific discipline such as Chemistry, Life Sciences, or Biology.

Experience: Experienced in regulatory submissions for medical devices.

Required Skills:

• Regulatory Submissions Experience
• Technical Leadership and Project Planning Skills
• Regulatory Compliance Understanding

Preferred Skills:

• Experience with Class II and Class III medical devices
• Familiarity with Quality Systems standards and ICH guidelines

ASSUMPTION: Given the seniority of the role, expertise in managing complex regulatory processes is expected.

💰 Compensation & Benefits

Salary Range: $98,000 – $196,000

Benefits:

• Career development and growth opportunities
• Comprehensive health and wellness programs
• Tuition reimbursement and education benefits

Working Hours: Standard 40-hour workweek

ASSUMPTION: The role offers competitive compensation with comprehensive benefits indicative of a senior position in the industry.

📌 Applicant Insights

🔍 Company Context

Industry: Hospitals and Health Care, focusing on innovative healthcare solutions.

Company Size: Over 114,000 employees, which provides extensive resources and global opportunities.

Founded: Not specified.

Company Description:

• Global leader in healthcare innovation and technology
• Wide array of life-changing technologies across healthcare sectors
• Strong international presence, serving over 160 countries

Company Specialties:

• Diagnostics
• Medical Devices
• Nutritional Products

Company Website: https://www.abbott.com

ASSUMPTION: As a large multinational corporation, Abbott's structure supports extensive career development opportunities.

📊 Role Analysis

Career Level: Senior-level, offering strategic involvement and leadership.

Reporting Structure: Likely to report to higher management within the Diabetes Care Division.

Work Arrangement: On-site, focused on team collaboration and onsite regulatory activities.

Growth Opportunities:

• Potential to influence significant company actions and product development.
• Involved in high-impact projects with visible outcomes.
• Opportunities to expand expertise in global regulatory environments.

ASSUMPTION: The role includes notable influence and opportunities to impact strategic business decisions.

🌍 Location & Work Environment

Office Type: Corporate office environment with opportunities for international collaboration.

Office Location(s): 2901 Harbor Bay Parkway, Alameda, CA

Geographic Context:

• Located in a prominent healthcare and biotechnology hub.
• Access to public transportation and major highways.
• Proximity to a thriving community with diverse amenities.

Work Schedule: Standard hours with some flexibility for project demands.

ASSUMPTION: Alameda's strategic location provides networking opportunities and access to industry resources.

💼 Interview & Application Insights

Typical Process:

• Initial application review and screening
• Technical interviews focusing on regulatory experience
• Final interviews with management and key stakeholders

Key Assessment Areas:

• Regulatory strategy and compliance expertise
• Leadership and project management skills
• Problem-solving and initiative-taking

Application Tips:

• Highlight regulatory successes in past roles
• Demonstrate strategic planning capabilities
• Prepare for scenarios related to cross-department collaboration

ATS Keywords: Regulatory Submissions, Medical Devices, Regulatory Compliance, Project Planning

ASSUMPTION: The interview process will emphasize strategic and technical expertise, underscoring leadership capabilities.

🛠️ Tools & Technologies

• Regulatory management software
• Document management systems
• Collaboration tools for cross-functional projects

ASSUMPTION: Proficiency with these tools will support the role’s regulatory compliance and strategic initiatives effectively.

👔 Cultural Fit Considerations

Company Values:

• Commitment to impacting health globally
• Innovation and leadership in healthcare
• Dedication to diversity and inclusion

Work Style:

• Collaborative and team-oriented environment
• Openness to ideas and problem-solving approaches
• Focus on results-driven work ethics and innovation

Self-Assessment Questions:

• Am I capable of leading cross-functional teams in a global setting?
• How do I approach problem-solving in regulatory contexts?
• Am I open to continuous learning and adapting to new technologies?

ASSUMPTION: Individuals who thrive in dynamic, collaborative environments that value diversity and innovation will be well-suited to Abbott's culture.

⚠️ Potential Challenges

• Managing complex regulatory requirements with multiple stakeholders
• Adapting to varying global regulatory environments
• Ensuring compliance amid rapidly changing technologies
• Balancing strategic oversight with daily operation demands

ASSUMPTION: Successful candidates will need robust adaptability skills and regulatory acumen to navigate potential challenges effectively.

📈 Similar Roles Comparison

• Comparable roles in other industries may not offer the same healthcare impact
• Positions in smaller companies may provide less robust resources
• Opportunities for influencing regulatory policies are typically more prominent at larger firms like Abbott

ASSUMPTION: This role is well-positioned for those seeking large-scale impact and involvement in cutting-edge healthcare technologies.

📝 Sample Projects

• Developing regulatory strategies for a new continuous glucose monitoring device
• Overseeing regulatory compliance during strategic product launches
• Management of regulatory liaisons for international business partnerships

ASSUMPTION: Sample projects illustrate high-impact, innovation-driven tasks that align with business objectives.

❓ Key Questions to Ask During Interview

• What are the key success metrics for this role?
• How does Abbott support professional growth and development?
• Can you describe the team structure and the reporting hierarchy?
• What challenges does the Diabetes Care Division currently face?
• How do Abbott's values shape decisions in the regulatory affairs team?

ASSUMPTION: These questions are intended to provide insight into role expectations and organizational goals at Abbott.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Prepare to discuss your regulatory strategy and compliance experience
• Emphasize teamwork and leadership experiences
• Highlight familiarity with global regulatory environments
• Articulate understanding of Abbott’s technologies and products

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.