Regulatory Specialist - Medical Device

• Keeping up-to-date with the Company's product range. Supporting submissions of registrations, licenses and renewals to strict deadlines ensuring the product certification matches product code/scope.
• Compile and review technical file for EU MDR to obtain/maintain CE marking.
• Assist in tracking standards, regulations and all applicable requirements, and feedback to the management.
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required.
• Stay updated on new and existing regulations, guidance documents, and standards, and communicate their impact on products and business to clients and internal teams.
• Support in specifying labelling and packaging requirements for compliance with US, EU, International submissions and applicable regulations.
• Work closely with the Notified Body to approve Change Notifications for medical devices.
• Participate in company regulatory and quality audits when required.
• Collaborate with cross-functional teams to ensure regulatory compliance at all stages of the product lifecycle.
• As and when requested carry out other regulatory tasks delegated by the manager.

Requirements:

• Minimum 3 - 4 years work experience in Regulatory Affairs for medical device products
• Possess at least a Bachelor’s Degree in Science from an accredited university
• Excellent verbal and written communication skills with strong English language proficiency
• Extensive knowledge of quality management system, ISO13485, 21CFR820, MDD93/42/EEC, MDR, MDSAP and applicable standards issued by the International Standards Organization (ISO).
• Strong computer skills required (including but not limited to Windows and Ms Office).
• Exceptional ability to work independently with minimal supervision, effectively organise, priorities and manage multiple projects
• Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work-related issues.
• Positive attitude, strong attention to detail and ability to solve problems independently
• Comprehensive understanding of regulatory activities and how they impact other products and/or processes
• Based in KL office, willing to exhibit flexibility in working hours to cater for the communications with the UK office.
• Open to non-Malaysians with a valid work permit or permanent resident (PR) status.

How do your skills match this job?

Sign in and update your profile to get insights.

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Regulatory Specialist?
• Which of the following Microsoft Office products are you experienced with?
• What's your expected monthly basic salary?
• How would you rate your English language skills?
• Which of the following languages are you fluent in?
• How much notice are you required to give your current employer?

Flexicare is a leading UK manufacturer of medical devices. Backed by over 40 years’ experience in design and development and supported by a modern manufacturing facility, Flexicare has built a world class reputation for the supply of medical devices. We currently supply anesthesia, respiratory care, critical care and urology products to more than 105 countries worldwide.