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Quality System Regulatory Affairs Specialist Apac
2 weeks ago
The Role
Responsible to maintain the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems (LMS and LBS divisions) Commercial Offices (CO) in APAC region.
**Your key responsibilities will include, and not limited to**:
Supports the APAC functional CO teams to maintain compliance with the QMS processes further interacting directly with 3rd party auditors during site assessments, providing overall leadership to the functional levels and support for all regulatory and quality assurance (RA/QA) related issues at CO side.
Make recommendations for the continuous improvement of QMS processes and directs resources in support of Key Performance Indicators (KPI) and other metrics. Responsible to verify effectiveness of QMS by internal audits.
Manage as admin the QMS platform for creation of quality documents and quality trainings
Responsible for product registration activities in APAC region where required. Maintain a positive relationship with relevant government and regulatory authorities. Support the APAC regulatory team in their registration activities
Responsible to coordinate post market surveillance (PMS) activities like adverse event/complaint, recall/field corrective actions in cooperation with the respective Business Units.
Validation of processes impacting on the QMS as needed.
**QUALITY MANAGEMENT SYSTEM**:
Maintain and continuous improve QMS
Support QMS harmonization effort within LMS
Support any departmental CAPA or non-conformance activities
**ENVIRONMENTAL MANAGEMENT SYSTEM**:
Develop environmental objectives and processes where applicable
Monitor overall environmental management system performance
Assure fulfillment of compliance obligations
Promote continuous improvement
Review the operation of the environmental management system
AUDITS (External and internal)
Primary point of contact for external audits
Performing and/or overseeing internal QMS Audits
TRAINING AND GUIDANCE
**Perform and/or oversee QMS training for**: LMS and LBS SU internal employees Sales, Service Customer Care and other departments in the regions as needed
Analyze, evaluate any applicable new/revised regulatory requirements in APAC market and explain/provide training to relevant stakeholders RA activities
Drive product registration activities in ANZ/APAC region and in other areas as requested
Maintain LMS products in ARTG and Medsafe database
Communicate with TGA and other government agencies and regulatory authorities as appropriate
Ensure compliance of LMS marketing material with TGA and other local advertising guidelines
Support IT department in their Master Validation Plan
**PMS**:
Coordinating RA/QA related activities (recall, field corrective action, adverse event) on Selling Unit side (direct interaction with RA/QA staff from BU)
VOC (Voice of Customer)
Supporting customer related quality issues (interface to BU) To be successful in this opportunity, a prior experience in the following criteria would be required: a) Professional Experience
Minimum 2-3 years proven QMS and/or RA experience in the Regulated Industry
International experience in problem solving, complaint handling or equivalent
Knowledge of Australian medical device regulatory requirements (preferred)
Knowledge of APAC region regulatory requirements (preferred) b) Education
Bachelor's degree (BA/BS) from four-year college or university required.
BSc degree or equivalent in science, engineering or equivalent (preferably) c) Language
English d)Travel (required estimated % of time)
Around 25%
**Highly Desirable capabilities**:
Strong quality focus.
Independent working approach
Experience in developing effective QMS as the foundation of high-quality products and services.
Hands on mentality in combination with solution-oriented mind-set.
Ability to communicate across all levels within the organization.
Strong analytical and organizational skills; ability for detail and precision (preferred)
Strong problem-solving skills
Well organized, able to prioritize, ability to see the bigger picture
High levels of integrity
Experience in holding presentations and trainings
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.
