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Change Controller

Req ID:  2400

Working Location: MASSACHUSETTS, WESTBOROUGH; MASSACHUSETTS, WALTHAM; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT; WASHINGTON, REDMOND 

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. 
 
Let’s inspire healthier lives, together.

Job Description

The Change Controller will lead the change control process as it relates to international regulatory affairs. They will review change orders and associated documentation to ensure compliance with change control requirements and determining whether regulatory submissions are required. The successful candidate will prepare impact assessments and communicate changes to international markets. The Change Controller will monitor feedback and liaise with marketing and supply departments to advise when contingency stock is necessary. They will maintain product registration dossiers affected by change orders to ensure that international registrations remain current. Preparation and submission of regulatory documentation for product registration and maintenance in selected global markets. The position requires extensive interaction and strong liaison with Olympus SBC teams for the introduction and maintenance of Gyrus ACMI devices to the respective markets

Job Duties

* Lead the change control process as it relates to international regulatory affairs.

 

* Review change orders and associated documentation to determine whether change notifications to international markets are required.

 

* Manage distribution to international markets and follow up communication to ensure compliance with global regulatory requirements.

 

* Lead the maintenance of international product dossiers by reviewing and monitoring changes to and identifying potential risks to existing and future business.

 

* Establish effective working relationships to liaise with Olympus S-BCs and local distributors to coordinate and maintain international submissions.

 

* Knowledgeable in the applicable global regulations and quality systems regulations.

 

* Provide guidance and expertise on international change process and mechanisms to the international RA team and to cross-functional teams by conducting searches and updates of applicable global regulations guidelines and standards to define and ensure understanding of the change process.

 

* Represent international RA in communicating change process initiatives or changes by leading global discussions within the organization and with global regulatory authorities.

 

* Exercise judgement in the oversight of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to senior management.

 

* Assist with the tracking of external standards applicable to company products and processes and maintenance of a corporate standards library/index and communication of proposed/implemented changes to company staff.

 

* Develop and facilitate the effective management of the process for obtaining and maintaining Certificates of Export from FDA or other applicable export notifications as needed.

 

* May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.

 

* Assist Director Intl RA and Executive Director RA during inspections by FDA and International Regulatory Agencies.

 

* Partner with development coordination preparation and maintenance of Core International medical device submissions such as EU design dossiers & technical files and Canadian submissions.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree is preferred, preferably in engineering or life sciences or advanced degree and/or other relative experience.

 

* Minimum of 5 years of regulatory affairs or medical device experience preferred; or other relevant experience required.
 


PREFERRED QUALIFICATIONS:

 

*  RAC accreditation (through RAPS) a plus

 

* Must be able to travel to Olympus facilities worldwide. 

 

* ISO 13485 ISO 9001 QSR experience preferred.

 

* Documented continuing education in regulatory affairs or RAC Certification is a plus.

 

* Foreign language is a plus.

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.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Engineer, QA, Quality Assurance, Engineering, Quality, Technology

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