Summary
The Regulatory Affairs Manager is responsible for driving regulatory submissions in China. Additionally, he/she will establish the quality management system in China to comply with import requirements and ensure site compliance activities in accordance with APAC policies and procedures. This position is authorized to implement all necessary s to ensure achievement of quality system ives. The position also monitors changes to applicable laws and legislations that could affect the organization in China and provides guidance to the site leadership team on matters relating to regulatory, quality and compliance. This position is based in Align’s China office and reports directly to the Associate Director, Regulatory and Compliance in the APAC corporate HQs located in Singapore with a dotted line to the site Managing Director.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop regulatory strategies, templates and documentation for product registrations for each new or modified product.
Manage assigned product registration and licensing activities in accordance with China regulations including filing determinations and submission content.
Compile information from multiple sources (e.g., project teams, corporate RA/QA, etc.) for submissions, guiding project teams in creating documentation for submissions, writing summaries and other necessary documentation for submissions.
Assist with product safety determinations and vigilance reporting activities.
Support product corrections and removals as directed by Corporate.
Interface with regulatory agencies on regulatory issues
Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products and complying with regulations.
Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with site process owners to define improvements.
Develop and maintain site Quality System policies and procedures to comply with import requirements. Coordinate with site personnel to ensure the success of site audits. Drive closure to audit findings including investigation, implementation, and effectiveness checks.
Develop and maintain site CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
Lead and/or assist project teams in Risk Management activities.
Assist personnel with Engineering/Document Change requests. Partner with Marketing to ensure the integrity of packaging, labeling, and promotional materials. Ensure integrity of site quality records.
Perform site compliance training, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
Collaborate with other departments (e.g., Marketing, Clinical, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution.
Escalate alleged violations of rules, regulations, policies, procedures, and Standards of Conduct. Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
Act as an independent review to ensure that compliance issues/concerns within the site are being appropriately uated, investigated, and resolved.
Implement the APAC compliance communication program at the site, including promoting (a) use of the Compliance Hotline (b) heightened awareness of Standards of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.
Identify potential areas of compliance vulnerability and risk or areas of increased enforcement attention develop/implement corrective plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
Provide guidance in complying with China regulations assist in developing rationale and documentation for new product development and product changes.
Travel may be required – up to 10%.
Additional Responsibilities:
Other duties may be assigned
QUALIFICATIONS
Candidate must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Must be 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.
Ability to balance between the growth needs of the company and the stringent compliance requirements associated with the healthcare services delivered by the company while ensuring compliance with the Standards of Conduct and all applicable laws and regulations.
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 ives, 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.
8-12 years of experience in Regulatory role at medical device company is required. Experience in Quality Assurance will be an advantage.
Thorough understanding of China 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.
Ability to research and propose well-thought out solutions when dealing with challenges.
