Regulatory Affairs (RA) Executive

Responsibilities

• Responsible to maintain and ensure company and product manufactured comply to regulatory and statutory requirements as well as providing support for issues related to regulatory and statutory requirements.
• Search, analyse, review, and summarize latest standard and regulation requirements for gloves.
• Assist on technical regulatory requirement for country registration matter including product registration, certification, external testing, product, and standard compliances.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statement, surveys, or questionnaires.
• Prepare, update and compile supporting documents for new and existing customer for country registration of Medical / examination / industrial gloves.
• Liaison with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review for establishment and product registration.
• Preparing documents for new 510 (k) submission for any new product development.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Assure the ongoing compliance by reviewing company practices and provide advice on changes to the system, such as Technical Files, ISO documentation and other regulatory issues.
• To prepare, review and update the technical files and all related regulatory documentation as necessary to obtain and sustain product approval.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Advise project teams on subjects such as premarket regulatory requirements, export and labelling requirements, or clinical study compliance issues.
• To ensure all functions are in accordance with the Medical Devices – Quality Management System (ISO 13485), ISO 9001, FDA Quality System Regulation (21 CFR Part 820, 803, 806), Medical Device Regulation (EU) 2017/745 Canada Medical Device Regulation SOR/98-282, Therapeutic Goods (medical Devices) Regulation 2002, MHLW Ministerial Ordinance No. 169, RDC ANVISA 67/2009 and Malaysian Medical Device Authority.
• Assist QA/RA Manager to file and investigate all incoming customer complaints and follow up on timely reply to the customer complaints by concerned department.

Skills

• Ability to work independently with minimum supervision
• Good written and oral communication skills.
• Strong computer skills are preferred.
• Ability to perform statistical analysis.
• Good interpersonal skills, systematic approach in executing jobs / assignments, strong / good organizing ability, dynamic personality.
• Good discipline and attitude.

Education

At least Bachelor’s Degree or equivalent in any field from accredited college or university, preferably in scientific discipline.

Experience

• At least 2 years working experience, preferably in a glove and cGMP environment.
• Knowledge of relevant regulation, standard and compliance requirement for medical devices is a must.
• Familiar with ISO 13845 and MDSAP requirements
• Knowledge of gloves manufacturing process, Quality Assurance, GMP, SOPs, and FDA in a regulated environment.
• General knowledge of current and proposed US & EU regulations for medical devices.