Sinclair is Hiring! Join Our Team as a Associated RA/QA Manager, APAC 🚀

We are currently recruiting for Associated RA/QA Manager, APAC at Seoul. 

About Sinclair

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Sinclair Values:

✅ Act with Integrity Consistently doing the right thing even when it’s the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines
✅ Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact
✅ Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
✅ One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way

✅ Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues

What You'll Be Doing:

To be responsible for regulatory matters and requirements within the company to achieve agreed targets and schedules in order to maintain current/obtain new authorisations/registrations related to company products for APAC including Korea markets in compliance with all relevant regulatory legislation and guidelines

Responsibilities and Accountabilities of the Role

For Korea

• To execute Class 1-4 medical devices and post-approval management

• To monitor related regulations and to establish regulatory strategy

• To consul on approval work with overseas cross-functional teams

• To perform full cycle management including approval renewal and change management

• To maintain KGMP and Korea quality system operation in compliance with local regulations

• To serve as the Quality Manager (QA) of Sinclair Korea and to lead regulatory inspection
• To provide leadership and direction in the area of site qualification process and management.

• To conduct the internal training to Sinclair Korea team

For APAC

• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices in APAC markets

• To work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions.

• To ensure all authorisations / registrations related to established products are maintained

• To monitor pending submissions to ensure timely approvals. Communicate to cross-functional teams any identified delays that may impact business expectations

• To interact with regulatory consultants, regulatory and trade associates and other third-party service providers to ensure their provision of any requested activities to agreed timescales

• To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities

• To review and approve product artworks and partner marketing material according to the applicable regulations

• To maintain all submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information

• To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs

• To raise purchase orders as necessary, manage invoices related to assigned work and assist in maintenance of tracking spreadsheets of costs for budgeting purposes

• To maintain monthly business reports as necessary

• To liaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessary

• To organise consular and translation services

• To facilitate agreement between SPL Legal and in-market partners regarding PoA/LoA expectations

To provide technical / regulatory input to CC Reg Assessments (APAC) and associated change notifications

Your skills and experience

Essential:

• Bachelor's degree (4 years) or higher
• 5-7 years of experience related to Korea medical device regulations
• 1-3 years of experience related to APAC medical device regulations
• Fluency in written and spoken English
• Native Korean
• Ability to work independently and to find the resource/solution for any challenges

Desirable:

• Preference degree in biomedical engineering, pharmacy, life science, chemistry, etc.
• Preference will be given to those with RA/QA experience in high-risk medical devices
• Preference will be given to those with medical device RA qualifications

What We're Looking For:

🔹List the job competencies from the job description here

We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

This is an exciting opportunity to join a successful company, with big ambitions for the future.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

Please note if we receive a high volume of applications, we may close the role before the closing date noted.

By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad.

Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void