Regulatory Affairs Senior Specialist (5 days Office hours, Monthly $4,500++)
- 1 year contract
- 5 days office hours
- $4,500++
- Work From Home Arrangement
Responsibilities
- Act as the Regulatory Affairs lead on Asia Pacific market expansion projects, including product registrations and renewals for assays, instruments, and software to support product launches.
- Prepare and review labels and submission documents, ensuring compliance with local regulations and guidelines. Maintain organized filing and documentation processes in line with Company standards, with a focus on regulatory compliance and audit readiness.
- Track, manage, and report on regulatory project timelines; help develop registration schedules to meet on-time RA deliverable deadlines by using system tools, matrices, and trackers. Identify project risks for escalation when necessary and adjust RA priorities to align with departmental and company objectives.
- Collaborate extensively with global cross-functional teams and external customers to maintain strong, communicative relationships, addressing submission queries and overcoming challenges.
- Act as an in-country representative and subject matter expert, providing insights on new or updated regulations and guidelines for sharing, as well as in-country regulatory requirements to the NPD core team for product development.
- Mentor junior associates and offer regulatory guidance to cross-functional teams.
Requirements
- Bachelor’s degree and/or above, in Life Sciences or related fields
- 3 or more years of direct regulatory experience in medical device or diagnostic industry, supporting at least 1 or more South-East Asia country or within Asia-Pacific region.
- Ability to work independently and maintain a "focused urgency" throughout the submission process.
- Strong written and communication skills, and comfortable to work in a dynamic multi-functional environment.
- Well versed in MS office and applications
Interested candidates who wish to apply for the advertised position, please click on “Apply Now”. Alternatively, you may email us an updated copy of your resume (Attn: NICH) or contact our office at +65 9834 1147 for a confidential discussion.
URL: https://go.persolkelly.com/job/apply/9993
Code: 9993
Job Code: NICH
EA Reg No: R23112658 (Nicholas Heng Zhe Xuan)
EA License No: 01C4394 (PERSOLKELLY SINGAPORE Pte Ltd)
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