Olympus America Inc. Executive Director, Quality & Regulatory Compliance in Southborough, Massachusetts

Job Duties::

As a team member building and leading the Regulatory Compliance team, you will be empowered and inspired to do your best work. You will contribute to our mission by utilizing your skills to assure that the company utilizes the tools required by regulations to delight our customers by assuring a state of regulatory compliance, while making sure the spirit of the regulation drives product and service quality. In this role, you will be tasked with building a compliance organization that not only helps Olympus maintain a state of Regulatory Compliance, but also drives quality improvement. You will sit on the RA/QA leadership team and report directly to the Group VP of RA/QA and have a voice on all aspects of the QMS. A typical day will include:

  • Influencing global RA/QA committee on strategic direction and initiatives.

  • Developing a Quality Regulatory Compliance framework that all Olympus can work to.

  • Establishing and managing the internal audit program at Olympus Americas.

  • Monitoring and advising on corrective actions in the Internal/External Audit system.

  • Developing and maintaining a Risk based Regulatory Compliance Dashboard for Olympus Americas.

  • Working with external regulatory compliance agencies to schedule the Olympus External Quality Audit process.

  • Monitoring external regulatory compliance environment and act as Olympus voice in shaping that environment.

  • Managing the Financial reporting and budget process for the Regulatory Compliance organization.

  • Evaluating Business Development targets to determine regulatory compliance gaps.

  • Leading department of regulatory compliance professionals both internal and external employees.

  • Proposing and justifying staff additions both from full time to contractor hires.

  • Managing Budget for regulatory compliance function

  • Performing all other essential duties as assigned.

Job Requirements::

REQUIRED QUALIFICATIONS:

  • Bachelor Degree is required; MBA is preferred.

  • Minimum of 10 years Regulated Quality experience is required; Medical Device experience is preferred.

  • Minimum of 5 years experience working for either the US FDA or an ISO Notified Body assessing compliance to QMS regulations; OR, minimum of 15 years experience in the regulatory compliance function at large ($10B annual revenue) multi-national medical device company.

  • Minimum of 3 years experience managing people.

  • Travel up to 25% of the time, location of this individual is not critical and can be based at any Olympus of Americas location, would even consider remote for correct individual

PREFERRED QUALIFICATIONS:

  • Good analytical toolkit.

  • Ability to influence outside of direct control at Senior And International Level (Up to C-Suite).

  • Expertise of the Global RA/QA regulatory landscape.

  • Understanding of the proper balance of being compliant vs. being value add in assessing the compliance to the quality management system.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

About Us:

At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.

We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.

THAT’S OLYMPUS.

TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.

Olympus Surgical Technology America

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled

Job Description:

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. We’re currently looking for an Executive Directory to join us in our Southborough, MA office.

Let’s inspire healthier lives, together.

The Quality/Regulatory Compliance group is responsible for establishing the QMS Regulatory Compliance strategy and designing and building the program that will assure Olympus is in a constant state of Quality System Regulation compliance. While an \"Americas\" based role, the incumbent will be key to assuring that the global Olympus organization is compliant to regulations in the Americas. He/She will be tasked with identifying the size and scope of the organization and effectively and efficiently making sure that Olympus is always improving to meet the changing regulatory environment.

Company URL:

Olympus Surgical Technology America at http://www.olympus-osta.com/

Posting Title:

Executive Director, Quality & Regulatory Compliance

Posting Locations:

Massachusetts, Southborough

Work Location:

Southborough GYR ACMI Inc

Job Family:

Quality Assurance

Auto req ID:

3819BR

3819BR

Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.