Post Market Regulatory Affairs

4 weeks ago

Malaysia Align Technology, Inc. Full time

Join a team that is changing millions of lives.

Transforming smiles , changing lives.

At Align Technology , we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.

Ready to join us?

About this opportunity

The APAC Regulatory and Quality Assurance Department has a position in APAC for a Post Market Regulatory Affairs (RA) Manager to support the region Post Market function. This role will establish, maintain, coordinate and support APAC Regulatory Compliance in Post Market across APAC sites and meeting Align’s Post Market goal to ensure that business processes across APAC are in full compliance with medical device regulations within the region and Align’s internal requirements.

The position also assesses the changes to applicable laws and legislations that could affect the organization in APAC and provides guidance to the APAC function on matters relating to Post Market. This position is based in Align’s Singapore office and reports directly to the Director, Regulatory Affairs and Quality Assurance, APAC, in the APAC corporate HQs located in Singapore.

In this role, you will…

  • Determine, create processes, and maintain Post Market Surveillance and activities for APAC Commercial sites, Manufacturing sites and products made by 3 rd Party manufacturers, in tandem with local regulatory requirements & Global directives.
  • Responsible as APAC Post Market RA lead to interface with Global/Site RAQA, cross functional teams for overall RAQA assessment, reporting, tracking & closure of Post Market activities inclusive of Recall, FSCA, Adverse Events for the region;
  • Responsible for the implementation and maintenance of APAC Post Market processes and to establish a Global Harmonized Post Market standard for Align commercial and manufacturing sites across APAC.
  • Responsible for evaluating region/local sites Change Controls/CAPAs, in collaboration with APAC/local RAQA, to determine if issues impact Post Market or requires further actions (e.g., recall) or reporting and coordinate with Global/APAC RAQA as needed.
  • Monitor and assess changes to Post Market regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with APAC process owners to define improvements.
  • Responsible for training of APAC sites on topics relating to Post Market.
  • Supports new business expansion in APAC, ensuring its Post Market compliance.
  • Assists with all department projects as required.

In this role, you’ll need …

  • Over 5-8 years in RAQA Post Market role at a healthcare/medical device company.
  • Fluent in English writing, reading and communication skills to interact with global and regional teams including external regulatory requirements
  • In depth knowledge of Medical Device and its Post Market regulations – APAC markets Post Market regulations, MDSAP, GMP, GDP, ISO 13485, etc., with its implementation experience.
  • Experience in performing processes mapping, workflows and writing SOPs, WIs.
  • Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
  • A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
  • Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
  • Ability to work independently, and handle both small and large matters with equal effectiveness and enthusiasm. Execute project/program tasks with general supervision and little guidance.
  • Ability to work cross-functionally with multiple projects, solving problems and communicating issues.
  • Must be able to thrive in a fast-paced environment with evolving regulatory landscape, be willing to adapt to change, as well as being capable of driving change.
  • Bachelor Degree in Science or Engineering preferred.
  • Ability to research and propose well-thought out solutions when dealing with challenges.

Sound like a good fit?

Great Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry,Alignis quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.

About Align

Align Technology is a publicly traded medical device company that is transforming smiles and changing lives . Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners andOrthoCADdigital services. Did you know? Align is the world’s largest manufacturer of custom 3D-printed materials.

By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of thethingsemployees say make Align Technology a great place to work.

We respect your privacy. Please reviewour for additional information.

Global Diversity Statement:

At Align, we believe in the power of a smile, and we know that everysmile isas unique asour employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a cultureof open-mindedness and compassion forallouremployees. We live our company values by promoting healthy people and healthy communities. All with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.

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