Change Controller

Job Description

Lead the change control process as it relates to international regulatory affairs. Review change orders and associated documentation to ensure compliance with change control requirements and determining whether regulatory submissions are required. Prepare impact assessments and communicate changes to international markets. Monitor feedback and liaise with marketing and supply departments to advise when contingency stock is necessary. 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

* Support Director International Regulatory Affairs in obtaining approval to market Gyrus ACMI medical devices in the worldwide markets by proactively leading and supporting the International RA team in obtaining and maintaining approval to market Gyrus ACMI medical devices in worldwide markets.

* Assist in leading 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.

* Expert knowledge of change control procedures. 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.

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

* Provide identification of budgetary needs for change control to the Director Intl RA. 

* 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. Provide reports to senior management regarding the progress of work-plans and the status of key project deliverables.

* Partner with Regulatory Affairs Department to implement company business plans.

* Assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor's degree 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.

* Must be able to travel to Gyrus ACMI facilities worldwide.

PREFERRED QUALIFICATIONS:

* RAC accreditation (through RAPS) a plus.

* Must be able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word Excel or Access Powerpoint).

* The ideal candidates will have the following abilities: Ability to work in small team environment but also self-starter with ability to work independently. Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors. Must be able to meet deadlines and be detailed orientated. Good planning and organization skills a must. Strong critical thinking and problem solving skills.

* ISO 13485 ISO 9001 QSR experience preferred.

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

* Foreign language is a plus.