Raqa Specialist

Operating Company: DEXIS
Location: Petaling Jaya,Selangor,MY
Date Posted: May 17, 2024
Req Number: R5019724

**The Role**:
In this role, you will ensure full compliance with any applicable regulatory and quality requirements of all regulatory bodies related to the import, export, supply and distribution of the products in Envista for countries in scope. Your portfolio includes but is not limited to digital imaging systems and associated treatment planning software, dental orthodontic products, dental restorative and endodontic products, and dental implant systems.

As a Regulatory Business Partner to the Commercial Team, you will provide strategies and executable regulatory plans supporting fast market access, commercial revenue, and growth targets. You must be knowledgeable and track local regulatory requirements. You will work closely with RA teams within local distributors, headquarters, and regional Platforms for strategy development and execution and bring local countries' requirements into global processes.

Act as a link between the company and regulatory authorities, ensuring that products are imported and distributed in compliance with appropriate legislation.

**Product Registration/Licensing Management**
- To drive competitive advantage, provide innovative regulatory strategies for new products and any changes in targeted markets.
- Identify implementation gaps and translate local/ global regulatory strategies into executable local plans.
- Managed product registration planning, including change notification and renewal, developed registration dossiers from regional dossier template for submission, and monitored progress, status, and timelines.
- Communicate and work closely with all relevant stakeholders, such as the Regional/ Global RA team, authorities, business partners, and regulatory consultants abroad, to deliver regulatory outcomes that enable business plans.
- Manage the regulatory approval for new registration and variations of medical devices in assigned geographies by ensuring quality and timely submission to regulatory bodies to add value to faster GTM and business growth.
- Obtain timely renewal of product licenses and maintain registration database.
- Manage applicable licenses/ certificates to ensure medical devices comply with any other applicable regulatory requirements of other regulatory bodies.
- Keep abreast of the regulatory changes and trends in assigned geographies and provide assessments of the impact of new and changing regulations on the company’s areas to the management. Keep businesses informed promptly on emerging regulatory issues and develop strategies to mitigate regulatorily

**RA/QA Matters Handling**
- Manage post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions, including product recalls. Collaborate with the Global QA team and business partners to ensure timely reporting to the Authorities until the closure.
- Implement and maintain the quality management system for dental platform entities in accordance with specific country requirements to possess a valid establishment and ensure business continuity.
- Develop and implement the required standard operating procedures and execution of training on regulatory and quality topics within the SEA region.
- Work with strategic business direction and perform with independent judgment, directly impacting the local markets' operations.
- Manage RA/QA partners screening and periodic review process using dental platform Channel Partner Toolkit (CPTK) and ensure our RA/QA partners in the SEA region act with the same level of integrity required of us under En vista's StandaEnvista's**ld Continuous Awareness within the Organization on Applicable RA Framework**
- Represent SEA Affiliate Regulatory Affairs' interest vigorously and be an outstanding business partner with regional sales and marketing teams.
- Establish and build relationships with key contacts within the organization to support the countries and strengthen relationships with industry associations, regulatory agencies, and external stakeholders.
- Lobby and influence the formulation of regulations, anticipate and shape the external environment to create or leverage opportunities, - participate in ad hoc projects.

**Relationship**
- Direct reports to Senior regional RAQA Manager.
- Work closely with regional & global RA/QA teams, Marketing, Commercial & Customer Service teams.
- Interacts with Finance and Service Engineers.

**External Relationship**
- Channel Partners
- Regulatory authorities
- Other relevant government agencies

**Measurement**
- Project delivered on time/report out
- Implementation of RAQA processes for continuous improvements
- Level of Envista Business System (EBS) zealotry and implementation

**Job Requirements**:
**Requirement for the Position**
- Education: A bachelor's degree from an accredited college or university is required. A Master's degree or PhD is advantageous. P