Regulatory Affairs Specialist
8 months contract, 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 a world-class US Healthcare company
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.
Company Description:
Our client is a US healthcare company with a broadly diversified business across consumer, pharmaceutical and medical device segments. They have an annual turnover of US$70 billion, with more than 125,000 employees across 60 countries with a heritage of more than 130 years.
Duties and Responsibilities
The Regulatory Affairs Specialist Medical Device is a member of the Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. This position will be responsible for stakeholder engagement and management including SEA Regional Regulatory Teams, Project Team, Master Data Team, and Regulatory Approval Database data steward.
Responsibilities include but not limited to:
- The Regulatory Affairs Specialist will be responsible to support the operational and administrative tasks of assigned Projects for SEA Countries.
- Assist in the review of SEA Countries’ registration information.
- Maintain departmental and source company databases of regulatory approvals.
- Work closely with SEA Regional Regulatory Teams to ensure project’s scopes, requirements and tasks are well-communicated and understood.
- Facilitate in strategizing effective approach, through proactively engagement/discussion and provide data analysis support, to ensure Project objectives are accomplished within a defined period of time.
- Attain and seek regulatory perspectives, feedbacks and queries from SEA country leads and consolidate in a concise manner for management reporting.
- Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient, and effective practices.
- Contribute to RA Team meetings to learn from colleagues, share experiences and best practice.
Requirements:
- Degree in any Science/ Pharmacy discipline with minimum 1 year of Regulatory Affairs experience
- Demonstrated ability to handle multiple projects.
- Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
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 [email protected]
EA License: 94C3609
Reg No: R1440247
