Contractor General

5 months ago

Singapur, Singapore Avanos Full time
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

This is a 6-month Maternity Cover position

• The Regulatory Affairs Specialist will assume primary responsibility in assisting to assist in the execution of the regulatory strategies in the assigned Central Asia (CA) and Middle East & South Africa (MEA) markets throughout the company product life cycle. This is to be done with a focus on efficient and timely pre-market and postmarket regulatory approvals for the company medical devices and other products as may be developed from time to time. The use of innovative compliant processes that balance the business needs is essential.
• He/she will also be responsible for the review and approval of change control activities, review and approval of product promotional activities, maintenance of product registrations and listings, review and approval of product labeling, assist with regulatory inspections and audits, and the management of all post market actions and associated activities in this sub-region with the support from Manager.

Job Position Accountabilities / Expectations

• Assist in providing regulatory input and technical guidance to global RA team on product regulatory requirements in the assigned markets throughout the product lifecycle
• Coordinate and support the development of optimum regulatory submission strategy for the assigned projects in collaboration with the respective global team and regional commercial partners including distributors; and update strategy based upon regulatory changes
• Coordinate, execute and support the planned regulatory submissions with the respective stakeholders
• Manage the preparation and if necessary submission of regulatory submission package to the respective health authorities
• Assist in identifyng and communicating issues early in the submission preparation stage that could impact product launch to the relevant stakeholders
• Work closely and efficiently with global RAQA team to provide appropriate responses to the health authorities queries during the evaluation process
• Close follow up with the respective health authorities during the evaluation process to ensure timely regulatory approvals
• Assist to review and recommend risk-based solutions on special marketing authorization routes with appropriate regulatory agencies to pursue approvals based on special needs
• Coordinate product post marketing approval requirements to ensure that compliance is in placed at all time
• Coordinate post marketing surveillance activities such as FSCA, product recalls, adverse event reporting, etc.
• Regularly and timely update internal stakeholders on projects status and product approvals
• Assist in product regulatory due diligence
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions with other rnernbers of regulatory and related teams
• Review and approve labelling and product promotional materials to ensure compliance with regulations and company policy
• Review and submit change controls to assess the impact of change and consequent regulatory submission requirements
• Keep abreast with current and latest regulations in the region; with the guidance from Manager to provide assessment on impact of new, existing and pending regulations, guidelines or standards to internal stakeholders timely
• Assisting in training for stakeholders on current and new regulatory requirements; regulatory and quality SOPs; and/or working procedures to ensure companywide compliance
• Compile and provide regulatory documents to commercial team and/or distributors in support of tender applications within the region
• Assist and participate as appropriate in regulatory inspections and quality audits
• Actively participate in professional or industry associations and if possible to be part of relevant working groups

Required Qualifications:
• Diploma or Bachelor's degree in life sciences or engineering background will be advantageous
• Regulatory and quality background preferably in medical devices or life sciences technology driven company with at least 2 years relevant experience

• IT-savvy and highly proficient in Microsoft Excel, Word and Power-point
• Good command of spoken and written English
• Team player
• Ability to work independently with minimum supervision


Preferred Qualifications:
• Knowledge of US FDA and EU medical device regulations will be advantageous
• Familiarity with IVD, drug-device/device drug, cosmetics or OTC products desirable
• Good business acumen and interpersonal skills
• Execution excellence
• Entrepreneurial and innovative
• Results oriented and driven individual
• Adaptable and agile

PRIMARY Responsibilities - focusing on pre- and post market activities

SECONDAY Responsibilities and this is optional based on candidate background - managing Quality Management System SS620. 


Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives,
people, and communities around the world.

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