Director, Business Development Quality Assurance - Remote

Lensa; Westborough (MA); Remote; USD 147,000 - 207,000; Full time

Job summary

A leading company in medical technology is seeking a Director of Business Development Quality Assurance. This remote role involves strategic support for business development projects, ensuring quality perspectives are integrated into diligence and integration efforts. The ideal candidate will have extensive experience in Regulatory Affairs and a strong understanding of global quality standards.

Benefits

Competitive salaries

Bonuses

401(k) match

Comprehensive health coverage

Employee Assistance Program

Wellbeing programs

Paid time off and parental leave

On-site amenities

Qualifications

• 15 years of Regulatory Affairs experience, including 10+ years in a global role.
• Experience managing a QMS and leading external audits.
• Knowledge of global quality and regulatory requirements for product development.

Responsibilities

• Provide in-depth analysis of Medical Device/Healthcare quality management systems.
• Guide global QA pathways and Quality System strategies.
• Oversee QA aspects of each project, including due diligence and risk assessment.

Skills

Regulatory Affairs

Project Management

Cross-functional Leadership

Communication

Education

Bachelor’s degree in a science-related field

Master’s preferred

Job description

Director, Business Development Quality Assurance - Remote

2 days ago Be among the first 25 applicants

Lensa is the leading career site for job seekers at every stage of their career. Our client, Olympus Corporation of the Americas, is seeking professionals. Apply via Lensa today!

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus (https://www.olympusamerica.com/careers).

• Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

The Director, Business Development (BD) Quality Assurance (QA) is responsible for strategic and tactical support for business development projects. This role will partner with the global BD team to ensure quality perspectives are integrated into diligence and integration efforts.

Job Duties

• Provide in-depth analysis of Medical Device/Healthcare quality management systems to support business transfer activities.
• Guide global QA pathways and Quality System strategies.
• Develop, maintain, and execute a QA M&A readiness plan, assessing current capabilities and planning for integration.
• Create tools and processes to support QA throughout the business development cycle.
• Coordinate resource planning and intra-QA efforts, maintaining visibility of projects.
• Ensure global regulatory requirements are incorporated into due diligence and integration activities.
• Maintain regulatory documentation for audits.
• Provide regulatory guidance to business units for QA decisions and strategies.
• Build and maintain a global network of resources across regions and divisions.
• Align with global and regional QA teams to ensure coordinated efforts.
• Oversee QA aspects of each project, including due diligence, risk assessment, and approval processes.
• Stay current on industry trends and train QA personnel on BD tools and processes.

Required Job Qualifications

• Bachelor’s degree in a science-related field; Master’s preferred.
• At least 15 years of Regulatory Affairs experience, including 10+ years in a global role.
• Up to 30% travel, domestic and international.
• Experience managing a QMS and leading external audits.
• Deep understanding of global submission and design control standards.
• Knowledge of global quality and regulatory requirements for product development and support.
• Experience with Business Development/M&A projects, including due diligence and post-merger integration.
• Strong cross-functional leadership skills.
• Excellent communication, project management, and global regulatory knowledge.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

• Competitive salaries, bonuses, 401(k) match
• Comprehensive health coverage
• Employee Assistance Program
• Wellbeing programs
• Paid time off and parental leave
• On-site amenities and more

Learn more about our benefits (https://www.olympusamerica.com/careers/benefits-perks).

The base salary range for this full-time role is $147,763 - $206,869/year, plus potential bonuses. Compensation depends on experience, location, and qualifications.

Olympus is committed to making a positive impact through innovative medical technology, with a focus on improving patient outcomes worldwide. We value diversity and inclusion, fostering an environment where all employees can thrive.