We are looking for a qualified professional to manage regulatory affairs, with a focus on GDPMD (Good Distribution Practice for Medical Devices), CDAKB (Indonesia), and product registration under the Medical Device Authority (MDA) Act.
This position entails ensuring compliance of medical devices with local regulations and standards, preparing and submitting registration applications, maintaining comprehensive product documentation, and coordinating with relevant regulatory authorities.
Job Description:
Supervise and manage the entire product registration process, ensuring strict adherence to regulatory requirements and timely submission of all necessary documentation.
Strategically plan, coordinate, and execute Regulatory Affairs (RA) activities within the assigned region, ensuring alignment with both regulatory standards and company objectives.
Oversee the complete regulatory lifecycle of products, including initial submissions, approvals, variations, renewals, and ongoing maintenance in collaboration with national regulatory authorities.
Conduct feasibility assessments for new product imports, ensuring compliance with national regulations and market entry strategies.
Compile, prepare, and review all required documentation for product registrations, ensuring submissions meet the necessary regulatory standards for approval.
Act as the primary liaison with national regulatory authorities, developing and presenting strategies for new product submissions and portfolio management.
Cultivate and maintain strong professional relationships with regulatory agencies to facilitate effective communication and negotiation on regulatory issues.
Monitor and stay informed about regulatory developments and trends, offering strategic advice on their potential impact on current and future product registrations.
Provide cross-functional support to internal teams, including marketing, sales, and R&D, ensuring that regulatory compliance is seamlessly integrated into product development and commercialization processes.
The RA region will not be limited to SIM but will also include other ASEAN countries where exports to distributors are anticipated.
Coordinate with the RA team at Menicon HQ to advance updates and registration tasks.
Job Requirements:
Degree holder in Science/Nutrition or a related field.
At least 2 years of experience as a Regulatory Affair.
A good command of spoken and written English and Bahasa Malaysia.
High attention to detail, with strong analytical and problem-solving abilities.
Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
Proven track record of successful product registrations, regulatory submissions, and lifecycle management in the pharmaceutical or healthcare sector.
Must have own transportation and be willing to travel when necessary for work purposes.
Your application will include the following questions:
What's your expected monthly basic salary?
Which of the following types of qualifications do you have?
Do you possess or have access to your own transportation?
How many years' experience do you have as a Regulatory Affairs Executive?
Are you willing to travel for this role when required?
Oculus Private Limited and its group of subsidiaries have over 25 years of experience in manufacturing and supplying high-quality contact lens and contact lens care products to optical retailers and eye-care practitioners.
Oculus is focused on the innovation, manufacturing, and marketing of cosmetic lenses.
Its core brands are FreshKon, Ocuviq, Boston, and Flexcon.
The Oculus group also offers disposable clear lenses primarily under the FreshKon brand and specialty products such as gas permeable lenses made with Boston material and soft toric lenses.
Oculus's products are manufactured in accordance with the quality assurance system ISO 9001 / ISO 13485 requirements and meet the Medical Devices Directive 93/42/EEC.
With a direct presence in Singapore, China, Hong Kong, Malaysia, Indonesia, and Taiwan, our products are sold globally in more than 50 countries.
Oculus is a fast-expanding optical company with regional operations.
We are looking for a dynamic and committed individual to be part of our team in Oculus (M) Sdn Bhd.#J-18808-Ljbffr