Manager Regulatory Affairs and Quality Assurance

LivaNova; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

LivaNova seeks a Regulatory Affairs and Quality Assurance Manager for its South Korean operations, overseeing compliance with local and global regulations in the medical device sector. Responsibilities include managing product registrations, implementing quality management systems, and collaborating with cross-functional teams to ensure product sustainability and customer satisfaction.

Qualifications

• In-depth knowledge of KGMP, ISO 13485 and product registration requirements in South Korea.
• Minimum 5–10 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.
• Experience working with MFDS and the Korean Medical Device Act.

Responsibilities

• Create regulatory strategies and submit product registrations with MFDS.
• Implement and maintain a Quality Management System in compliance with KGMP and ISO 13485.
• Liaise with regulatory authorities during audits and inspections.

Skills

Knowledge of Medical Device Regulations

Analytical Skills

Communication Skills in Korean

Communication Skills in English

Interpersonal Skills

Quality Systems Development

Problem-Solving

Education

Bachelor’s degree in Pharmacy, Life Sciences, Medical Technology, Biomedical Engineering or a related field

Job description

Join us today and make a difference in people's lives!

Position Summary:

This role will lead and manage the quality assurance and ensure full regulatory compliance for the commercial operations of the LivaNova’s South Korean subsidiary. This includes oversight of regulatory submissions, distribution compliance, complaint handling, post-market surveillance and quality-related regulatory activities within South Korea for LivaNova’s medical devices imported and distributed there.

This role manages product registrations with the Ministry of Food and Drug Safety (MFDS), maintains compliance with the South Korean Medical Device Act, and oversees implementation and maintenance of a KGMP-compliant Quality Management System. The RAQA Manager serves as the key contact point for regulatory authorities, ensures smooth product market entry, and upholds high-quality standards across the supply chain.

The individual will ensure that all commercial quality activities align with both global corporate policies and local regulatory requirements (e.g., KFDA regulations, Quality standards), while fostering a strong culture of compliance, collaboration, and continuous improvement.

As a key member of the entity, this role will partner cross-functionally with Supply Chain, Commercial, Legal, and Global Quality functions to support product availability, customer satisfaction, and regulatory compliance.

Primary Duties and Key Responsibilities

Regulatory Affairs (RA)

• Create regulatory strategies based on the regulatory and commercial landscapes
• Submit and manage product registrations, changes and renewal applications and processes with MFDS
• Monitor changes in applicable South Korean regulations and standards (e.g., KGMP - Korea Good Manufacturing Practice) that may impact current or future product portfolios
• Ensure compliance with all applicable requirements under the South Korean Medical Device Act and MFDS regulations for importers and distributors
• Liaise with MFDS and local regulatory authorities during audits, inspections, or queries
• Coordinate and support overseas manufacturers to obtain necessary documentation, certificates (KGMP Certificates, Free Sales Certificate, ISO 13485, etc.) from MFDS as required
• Monitor regulatory changes in South Korea and globally
• Manage labeling and promotional material compliance in accordance with the relevant South Korean regulations and guidelines
• Secure relevant licenses (e.g., environmental, telecommunications-related & etc) for import and sale of the devices imported by LivaNova Korea in accordance with local regulations and guidelines by other government agencies in South Korea

Quality Assurance (QA)

• Implement and maintain a Quality Management System (QMS) in compliance with KGMP (Korean Good Manufacturing Practice) and ISO 13485
• Act as the quality representative (or management representative) advising on quality risks, opportunities, compliance matters and influencing decisions from a quality and compliance perspective
• Manage, control and support local labeling process for all devices imported into South Korea by LivaNova
• Oversee quality control of imported medical devices, including inspection processes, document checks (e.g., CoA, shipping records), and release procedures
• Manage vigilance reporting and adverse event submissions to MFDS
• Manage supplier qualification and audits of overseas manufacturers when required
• Conduct internal audits, manage CAPAs, non-conformances, and implement corrective actions
• Lead preparations for and execution of MFDS inspections and third-party audits
• Ensure training programs are in place and effective for staff involved in sales, QA and regulatory compliance
• Foster stronger collaboration with other departments (e.g., sales, marketing, customer services and manufacturing, customer service) to ensure quality is integrated across all functions
• Oversee complaint handling, adverse event reporting, and field action coordination in accordance with global and local requirements
• Monitor post-market product performance and ensure timely resolution of customer quality issues
• Work with Business Unit (BU) Customer Quality and Quality Engineering to understand the significance & impact of field action (if initiated by LivaNova), and the actions required at country level for effective execution of the field action/ recalls
• Support, train, inform and coordinate with the sales & marketing team on the initiation of FSCA and address all applicable questions after consultation with BU Customer Quality

Education/ Qualification /Experience

• Bachelor’s degree in Pharmacy, Life Sciences, Medical Technology, Biomedical Engineering or a related field
• In-depth knowledge of KGMP, ISO 13485 and product registration requirements in South Korea
• Strong understanding of the role and responsibilities of a legal representative (importer) in the South Korean regulatory landscape
• Minimum 5–10 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry, including experience working with MFDS and the Korean Medical Device Act

Knowledge, Skills and Abilities Required:

• Knowledge of South Korea’s Medical Device Regulations and Quality System Requirements
• Experience dealing with Class II, III, or IV medical devices
• Knowledge of UDI (Unique Device Identification) system and post-market surveillance requirements in Korea
• Certification as KGMP internal auditor or equivalent.
• Proven track record in quality systems development and implementation.
• Proven track record of handling MFDS submissions and inspections.
• Experience working in a multinational or cross-cultural team.
• Excellent communication skills in Korean and English (both written and verbal)
• Great interpersonal skills;
• High analytical skillswithabilityto collect and analyze information, problem-solve;
• Highly organized, detail-oriented, and able to manage multiple priorities
• Good time-management skills.
• Self-motivated, critical thinker, problem-solving attitude, quick in action, good team player

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.