Regulatory Affairs Specialist(1 year contract)

Korea, Republic of

Duties & responsibilities:

• Support the commercial organization in Korea to ensure their timely registrations and license renewal success.

• Implement the communications and documentation between Business Units, distributors, global RAQA and manufacturing.

• Execute and maintain quality management activities, including but not limited to the QMS management, CAPA, and Field actions. Implement necessary measures to comply with Hologic Quality Manual and related SOPs. Take timely and appropriate quality management actions and executing communications with government and internal/external customers.

• Closely collaborate with global RAQA, Customer service and Supply Chain.

• Regular review and revise QMS documents to reflect local and global quality requirements in timely manner and ensure the suitability of and effectiveness of QMS. Medical device importer’s duties management.

• Keep abreast of all government pre-market and post-market activities including but not limited to product registrations/change notifications/re-registrations/license renewals/input requests-questions and other related actions in Korea to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans.

• Identify and report potential issues that may impact the regulatory strategy and timeline for products registrations and develop and propose solutions to mitigate the risk and outcome.

• Conduct the product registration projects for all Korea as assigned.

• Ensure registration activities are completed on-time based on business priorities Including timely follow-up coordination with manufacturing sites for support and documentation.

• Support sales and marketing on tenders and operational issues.

• Review, improve and maintain the processes to meet corporate and latest/prevailing regulatory requirements.

• Maintain records, tracking, master data, monthly reporting and documents.

• Maintain and develop a Regulatory intelligence database and be capable of analyzing the information available.

• Support Post Market Activity and ensure timely and correct reporting/ follow up to authority.

• Coordinate/Report and keep track of FSCAs.

• Support QA issues, coordinate and facilitate internal commercial and distributors.

• Any other duties as assigned by the Manager.

The Person

The successful candidate will have in-depth understanding of the Korea Medical device and IVDs regulatory environment. He / She must be able to work collaboratively and excel within a results-oriented environment where regulatory activities must be executed timely and accurately. He / She must be highly accountable and be able to multi-task and prioritize.

In addition, the successful candidate will possess:

• Proven product registration success track record across multiple product lines.

• Good knowledge of current Korea regulatory requirements.

• Demonstrated success with establishing and maintaining existing regulatory authority contacts and opening new communications with competent authorities.

• Multi-national company experience with specific success working for US or European based companies.

Qualifications / Education

• A bachelor’s degree in science, engineering, medical or related

• A postgraduate degree as well as regulatory proficiency based on certifications is desired.

• 3 to 5 years of relevant RA experience with the medical device or IVDs industry. QA experience would be advantageous.

• Excellent communication skills with ability to effectively interact at working levels as well as cross-cultural awareness. Work well with cross-functional teams.

• In-depth knowledge of Korea medical device act and regulations, ISO13485.

• Good reading and written English skill.

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