Location Options: Massachusetts (Westborough), Minnesota (Brooklyn Park), Pennsylvania (Center Valley)

Work Arrangement: Field-based position

For over a century, Olympus has been dedicated to enhancing the health, safety, and fulfillment of people’s lives.

We embody our philosophy, “True to Life,” by pushing the boundaries of medical technology and elevating patient care standards globally, helping individuals achieve their aspirations and live their best lives.

Our five Core Values inspire our mission:

Patient Focus, Integrity, Innovation, Impact, and Empathy.

Explore more about Life at Olympus () .

Please be cautious: All official communication will originate from our Olympus email domain. Any correspondence from other sources may not be legitimate.

Position Overview

The Director of Business Development (BD) Quality Assurance (QA) plays a pivotal role in providing strategic and tactical support for our business development initiatives. This essential position collaborates closely with the global BD team to ensure the integration of quality assurance perspectives in all diligence and integration activities.

Key Responsibilities

• Conduct comprehensive analyses of Medical Device/Healthcare quality management systems to facilitate the transfer of business activities.
• Offer strategic direction on global QA pathways and develop, maintain, and execute a robust QA M&A readiness plan.
• Evaluate existing capabilities, policies, processes, organizational structures, and resources to ensure effective QA due diligence and integrate best practices.
• Innovate tool and process development through continuous improvement to bolster QA initiatives throughout the business development cycle.
• Formulate a clear implementation plan that is mutually agreed upon by BD and QA senior leaders.
• Oversee resource planning and intra-QA coordination, keeping an updated view of all projects within the business development pipeline.
• Ensure that all global regulatory requirements are considered and integrated into due diligence and subsequent activities.
• Maintain meticulous regulatory documentation that is organized and ready for audits by global regulatory bodies.
• Gain insight into business unit strategies and product portfolios to provide regulatory strategy guidance to Business Unit Leaders and stakeholders.
• Foster relationships across all regions, businesses, and divisions to build a robust resource network.
• Ensure functional alignment by coordinating with global and regional QA teams for approvals and resource assignment.
• Take ownership of all QA facets in each business development project, overseeing due diligence and integration activities and securing necessary approvals.
• Stay informed on industry trends by reviewing relevant quality and regulatory intelligence reports, applying insights to evaluation and integration strategies. Provide training and coaching on BD tools and processes to QA personnel.

Qualifications Required

• Bachelor’s degree in a science-related field; Master’s degree is an advantage.
• A minimum of 15 years of relevant Regulatory Affairs experience, including at least 10 years in a global setting.
• Willingness to travel up to 30% (based on project needs), both domestically and internationally.
• Strong knowledge and experience in managing a Quality Management System and leading external QMS certification and surveillance audits.
• In-depth understanding of global submission requirements and design control standards necessary for compliance with global Health Authority standards.
• Extensive knowledge of global quality and regulatory requirements related to new product development and maintaining market access.
• Experience with Business Development/M&A projects, specifically in due diligence and post-merger integration.
• Proven ability to collaborate and drive cross-functional initiatives.
• Demonstrated leadership skills with a passion for achieving goals; an excellent team player.
• Global insight into product domains and vital technology/therapeutic areas/R&D disciplines.
• Exceptional leadership and interpersonal skills, with an ability to engage effectively across diverse cultures.
• High business acumen coupled with the agility to learn and adapt quickly.
• Strong communication skills, verbally and in writing, along with the ability to distill complex information into actionable recommendations.
• Ability to influence senior decision-makers while navigating organizational complexities.
• Solid project management skills, including planning, budgeting, and resource allocation.
• Thorough understanding of the roles and responsibilities across R&D functions.
• Practical familiarity with global regulatory and quality standards and requirements.

Why Choose Olympus?

We are committed to offering a comprehensive employee experience focused on personal and professional well-being through purposeful work, equitable benefits, and a cohesive culture.

Equitable and Competitive Benefits:

• Attractive salaries, annual bonuses, and a 401(k) plan with company contributions.
• Extensive medical, dental, and vision coverage starting on your first day.
• 24/7 Employee Assistance Program for support anytime you need it.
• Complimentary access to live and on-demand Wellbeing Programs.
• Generous vacation and sick leave policies.
• Paid parental leave and support for adoption.
• 12 paid holidays to recharge.
• Convenient on-site childcare, café, and fitness center.

A Culture of Connection:

• Work-life integrated culture that champions an employee-centric approach.
• Flexibility in work environment: onsite, hybrid, or field-based.
• Initiatives supporting paid volunteering and charitable donations with matching programs.
• Strong focus on Diversity, Equity, and Inclusion, featuring Employee Resource Groups.
• Access to dedicated training resources and developmental programs.
• Financial assistance for continued education.

For U.S. locations only, including Center Valley, PA, and Westborough, MA.

Ready to join our team?

Discover more about our benefits and incentives () .

The anticipated salary range for this full-time role is $147,763.00 – $206,869.00 per year, with the possibility of an annual bonus (subject to eligibility). Olympus evaluates various factors when determining compensation, including experience, location, and relevant qualifications.

At Olympus, we are dedicated to our mission of enhancing the health, safety, and well-being of individuals. As a global medical technology leader, we collaborate with healthcare professionals to deliver top-notch solutions for early detection, diagnosis, and minimally invasive treatment, all aimed at improving patient care standards.

With our headquarters in Tokyo, Japan, Olympus employs over 31,000 individuals in nearly 40 countries. Olympus Corporation of the Americas, a subsidiary of Olympus Corporation, is situated in Center Valley, Pennsylvania, employing more than 5,200 people across North and South America. For additional information, visit us at .

At Olympus, we prioritize building a diverse and inclusive workplace.

We value diversity in perspectives and lifestyles, emphasizing inclusion and mutual respect. Our goal is to foster an empathetic and unified environment where every employee can thrive.

Let’s unlock your potential together.

Olympus is an equal opportunity employer, committed to providing employment and advancement opportunities regardless of race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, and breastfeeding), and other protected characteristics as established by law.