Regulatory, Quality and Government Affairs Manager

Job Description

Description

Join a team that is changing millions of lives.
Transforming smiles. Transforming lives. Transforming an industry.

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 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 Korea for the Regulatory, Quality and Government Affairs Manager to support these local functions of the Department. The role is to focus on regulatory submissions, quality management system and government affairs effort in Korea and to overall support the APAC RAGA Director in achieving the department goals from a local level, cascading to APAC level.

In this role, you will...

Regulatory Affairs

• Represent Align’s policy interests in Korea as agreed with APAC RAQAGA Department, the site leadership team and U.S. headquarters.
• Responsible for leading the Korea Office in complying with Korean medical device regulations; to conduct impact assessment, develop rationale and documentation for new product and product changes.
• Work collaboratively with APAC RAQA, project teams and U.S. headquarters, to prepare and submit regulatory submissions to the MFDS and/or notified bodies for new or change submissions.
• Ensure that annual or time limited product approvals/site licenses are renew/maintain to ensure product supply.
• Conduct post market obligations and coordinate with APAC RAQA and U.S. headquarters to ensure timely reporting of adverse events.
• Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align, propose action plans to APAC RAQAGA and see through agreed plans.

Quality Assurance

• Responsible for developing and maintaining the site Quality System policies, procedures and quality records to comply with local QMS requirement. These include import documentation, training records, complaint handling records, CAPA, MR records etc. Assume the role of Management Representative of QMS.
• Develop and maintain site CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
• Coordinate with site personnel to ensure the success of site audits including overseas KGMP site audits of manufacturing facilities, corporate audit.
• Drive closure to audit findings including investigation, implementation, and effectiveness checks.
• Work collaboratively with process owners to define and execute quality improvement plans.
• Lead and/or assist project teams in Risk Management activities.

Government Affairs

• Propose and coordinate position development of Align and assist with the lobbying strategy in Korea.
• Establish a solid discussion channel and further develop relationships with local government officials in Korea.

Others

• Assist with all department projects as required.
• Participate in proactive team efforts to achieve departmental and company goals.
• Provide support to audit processes and quality management system as required.

In this role, you’ll need ...

• Proficient in English, with a working knowledge of other APAC languages.
• Must understand the regulatory requirements for Class I and II medical devices.
• Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
• Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
• A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
• Must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
• Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.

EDUCATION and/or EXPERIENCE

• Bachelor Degree in Science or Engineering preferred.
• 8 years of experience in Regulatory, Quality Assurance and Government Affairs role at medical device company is required.
• Thorough understanding of Korean medical device laws and regulations.
• Extensive experience in performing all regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) and medical device, software-related regulatory requirements.
• Significant experience within the legislative and regulatory fields applicable to medical devices, including interaction with government officials at the Ministry of Food & Drug Safety and the Ministry of Health & Welfare.
• Extensive experience in performing QMS functions to comply with local requirements.
• Demonstrated ability to ability to build and maintain relationships with decision and policy makers within the Korean government.
• Excellent knowledge of the Korean legislative and regulatory landscapes and processes.
• Ability to research and propose well-thought out solutions when dealing with challenges.

Sound like a good fit?

Great! Click the Apply link below to let us know you are interested. Not the right fit? Don’t worry, there are lots more opportunities. Please consider sharing this opportunity with others in your network.

About Align

Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.

We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/