Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
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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.
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Your application will include the following questions: What's your expected monthly basic salary? How many years' experience do you have as a Regulatory Affairs Executive? Have you worked in a role which requires a sound understanding of ISO 9001? Do you have technical writing experience? How would you rate your English language skills?
Manufacturing, Transport & Logistics101-1,000 employees
New medical glove manufacturing company located at Kamunting, Perak. Wholly-owned subsidiary of a Company listed in Bursa Malaysia with a clear mission and vision to create value in the industry through our business culture and direction.
OUR VISION - Leading Gloves Innovator and Manufacturer
MISSION - Innovate with most advance technology in manufacturing the highest quality products with lowest waste and highest efficiency. To always deliver with integrity and in a timely manner
VALUES - Morality |Quality | Innovation | Commitment | Team-work
New medical glove manufacturing company located at Kamunting, Perak. Wholly-owned subsidiary of a Company listed in Bursa Malaysia with a clear mission and vision to create value in the industry through our business culture and direction.
OUR VISION - Leading Gloves Innovator and Manufacturer
MISSION - Innovate with most advance technology in manufacturing the highest quality products with lowest waste and highest efficiency. To always deliver with integrity and in a timely manner
VALUES - Morality |Quality | Innovation | Commitment | Team-work
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What can I earn as a Regulatory Affairs Executive#J-18808-Ljbffr