Regulatory Affairs Specialist (Medical Device)

Regulatory Affairs Specialist (Medical Device)

1 year contract, high potential to renew

Come and join us!

Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

“FIND YOUR PLACE” by joining our client Johnson & Johnson

Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Johnson & Johnson WORKSENSETM (via Randstad Sourceright) is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.

As an equal opportunity employer Johnson & Johnson value diversity at their company. They don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Description

·        The Regulatory Affairs Specialist will be a member of the local Regulatory Affairs Medical Devices department, with responsibility for regulatory aspects of the assigned product portfolios or Projects.

·        Preparation of submissions to the local health authority for medical devices registration and changes to existing products in line with Marketing launch plans

·        Maintain internal and source company databases of regulatory approvals

·        Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements and request the documentation required for registration submissions

·        Build constructive relationships with the local health authority by compiling and submitting required documents and providing responses to questions via return applications

·        Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio

·        Contribute to continuous review and improvement of processes within the Regulatory Affairs department to ensure consistent, efficient and effective practices across the team

·        Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice

·        Assist Regulatory Affairs colleagues in supporting other product portfolios or regulatory activities, as required

Requirements

·        A bachelor's degree, preferably in Biomedical Engineering, Pharmacy, Life Science or any related discipline; with 1-2 years’ experience in Regulatory affairs

·        Familiarity with the regulatory systems and product registration requirements is desirable;

·        Previous experience in preparing documents for health authority submissions (medical devices) is desirable.

·        Demonstrated ability to handle multiple projects;

Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.

Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button.

      Alternatively, you can share your CV at joleyn.chin@randstadsourceright.com.sg

EA License: 94C3609

Reg No: R1440247