Regulatory Officer - #1128968

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components. The Group provides one-stop, turnkey plastic solutions, with capabilities ranging from product & mould designs, mould fabrication, injection moulding, complementary finishings, through to the precision assembly of complete products.

Boasting a total factory space of more than 4 million sq feet, with more than 1,000 injection moulding machines and a tooling capacity of 2,000 moulds per year, Sunningdale Tech is focusing on serving four key business segments – Automotive/Aerospace, Consumer/IT, Healthcare and Tooling.

With manufacturing facilities across Singapore, Malaysia (Johor, Penang), China (Tianjin, Shanghai, Suzhou, Zhongshan, Guangzhou, and Chuzhou), Latvia (Riga), Mexico (Guadalajara), North America (Phoenix), India (Chennai), Thailand (Rayong), and Indonesia (Batam), Sunningdale Tech is strategically positioned to target and capture opportunities in diverse business sectors globally.

As an industry leader with deep engineering expertise and experience, Sunningdale Tech is driven to solve your challenges by applying our advanced capabilities & leading technology in ways that benefit you. We’re ready to provide solutions at every step of the process to reduce lead time and add value for customers, while maintaining our excellent quality. Beyond that, we build on our strong foundations to think out of the box and apply relevant new possibilities for your complex engineering problems. Customers can trust us to constantly solve challenges to meet their needs, and apply new ideas for better outcomes.

Responsibilities:

• Responsible for the execution of all compliance activities, to ensure a sustainable state of compliance to applicable regulations, standards and internal policies and procedures.

• Responsible for Medical Device’s Compliance data gathering, analysis, reporting and communicating the output of the data analysis, trends and conclusions to Senior Management.

• Responsible for supporting the development of the compliance strategies and execution of such strategies, the implementation of proactive compliance projects and Initiatives, Internal Audit program, as well as providing compliance guidance, including compliance support for Quality improvement and remediation activities.

• Support New Product Development (NDP) projects as needed, Quality & Compliance activities, Technical File, Technical dossiers, Regulatory submissions, Registration, for targeted markets and per customers’ and organization’s requirements.

• Serves as the Regulatory compliance expert for cross site and cross segment’s project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.

• Alert organization to any existing and potential problems and risks

• Responsible for communicating business related issues or opportunities to next management level

• May require contact with external functions such as Regulatory Agencies (e.g. FDA), and Notified Bodies (e.g. TUV, HSA).

• Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations through the development of Standard Operating Procedures.

• Keep abreast of new standards and regulations Responsible for maintenance and publishing of regular applicable regulatory update within the organization, compliance but not limited to CE, FDA, HSA, Food Safety.

• Compilation of technical dossiers, technical files, regulatory submissions for target markets and per customers’ and organization’s requirements.

• Responsible for Product and establishment registration and maintenance for Sunningdale tech groups of companies, including product recall.

• Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, ISO 13485 / FDA 21 CFR Part 820 regulations, International standards, and customer specific regulatory requirements.

• Work with purchaser for request with regards to updated regulation declaration / compliance letter from supplier to ensure used material comply to relevant customer, medical devices and food safety requirements.

• Issue regulatory declaration / compliance letter to customers to ensure our product meets customer requirements.

• Any other duties as and when assigned

Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirements:

• Degree in Medical Devices, Biomedical, Biopharmaceutical or Pharmaceutical related

• Minimum 2 years experience in Quality System - Internal/Lead Auditor

• Knowledge of molding and assembly manufacturing process flow, inspection system, sampling technique and customer specific requirement.

• Strategic thinker as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills

• Ability to understand procedural documents and evaluate documents to ensure compliance with all applicable regulations and requirements

• Operational Quality experience in at least one of the following areas: Medical Device, Biopharmaceutical or Pharmaceutical products

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Only shortlisted candidates will be notified

Sunningdale Tech is an equal opportunity employer – we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.

All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.