Raqa Specialist, Southeast Asia

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Position title:
RAQA Specialist, Southeast Asia

Department:
RAQA

Reports to:
RAQA Manager, Southeast Asia

About Applied Medical

As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference.

Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally.

We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth.

We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged. Applied Medical's products have been serving the Asian markets for over 20 years.

To build sustainable partnerships in particular to Southeast Asia (SEA) markets, we are investing in hiring Regulatory and Quality (RAQA) team members.

Overall responsibilities
The RAQA Specialist will be responsible for regulatory and quality projects and improvements to meet company goals.

This includes ensuring compliance to Regulatory Affairs (RA), Quality Systems (QS) and Quality Assurance (QA) requirements in SEA markets for Applied Medical products by performing premarket and post-market activities.

The specialist must be capable of working within a team environment, striving to meet or exceed customer expectations.

Essential duties
Ø Obtain product registration approvals from relevant authorities according to organization's

regulatory plan and strategy in SEA by compiling dossier as per local medical device regulations and collaborating closely with Headquarter Premarket team and authorities/distributors.

Ø Assess impact on registrations for changes initiated by Product Owner and communicate impact to relevant stakeholders.

Ø Prepare, submit, and obtain approvals in a timely manner for changes initiated by Product Owner for continued market access.

Ø Timely renewal of product registrations.

Ø Monitor, prepare, and support compliance to adverse events reports, recalls and other required post-market surveillance regulations.

Ø Participate in internal and external audits as required.

Ø Support the implementation and compliance of Quality Management System in Singapore.

Ø Keep abreast with changes in the regulatory environment in SEA.

Ø Perform additional duties and responsibilities as required by leadership.

Other duties and responsibilities
Ø Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions and decision making.

Ø Build necessary relationships with internal and external stakeholders.

Ø Support the Field Implementation team with relevant documents for tender submissions.

Ø Identify and implement systems to improve the overall efficiency of processes.

Ø Perform additional duties and responsibilities as required by leadership.

Position qualifications
Knowledge, skills, and abilities

Ø Effective in obtaining and maintaining Marketing Authorizations or Registrations for medical devices, including handling change management.

Ø Experience in performing post-market activities, such as adverse event reporting and handling of recalls.

Ø Competent in supporting QMS on-site and document audits.

Ø Preferred knowledge in ISO 13485, ISO 14971, ISO 60601, GDP.

Ø Familiarity with supplier control and experience working with 3PL and/or 4PL.

Ø Ability to work independently and as part of a team.

Ø Able to multi-task, organize and prioritize.

Ø Analytical, meticulous and detail oriented.

Ø Assertive and not afraid to ask questions.

Ø Friendly, good attitude, customer service oriented.

Ø Effective oral and written communication and presentation skills in English.

Education
Bachelor's degree in engineering, physical or biological sciences, regulatory, other technical

discipline, or equivalent preferred.

Training in Quality Systems including GDPMDS.

Experience
1-2 years of experience in Regulatory Affairs and/or Quality Assurance in the medical device

Industry.

Materials
General office equipment

Microsoft Office Suite

SAP
Adobe Suite

Internet

Working environment
Home-office environment

Location:
Singapore

Benefits
Applied offers benefits package following local labor laws

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