Senior Regulatory Operations Manager (Medical Device Industry)
Medical Devices Industry
About Our Client
A medical device company which is the headquartered in Singapore. They have R&D facilities in Japan and Singapore; a manufacturing plant in Singapore; sales and marketing offices in Europe, Japan, Singapore, and U.S
As Senior Regulatory Operations Manager (Medical Device Industry) you will be reporting to Specialist Regulatory Operations and your responsibilities will include but not limited to:
- Responsible for people management of the direct report(s), including objective setting, performance review, and coaching and development.
- Participation in local, regional and/or global level in projects where regulatory input is required.
- Owns the Global Submission Plan and ensures that the plan stays up-to-date by continuous dialogue with key stakeholders
- Flags and facilitates discussions on resolving issues in the Global Submission Plan between Global Operations and Supply Chain, R&D, Registration Managers, Global Product Directors, and Global Regulatory Product Owners
- Monitors progress in execution of the Global Submission Plan and facilitates the process of proactively finding solutions to reduce timeline risks.
- Serves as the liaison between Global Operations and the Regulatory Organization in relation to planning for product and process improvements as well as labelling creation/revision.
- Responsible for assessing and approving CCRs and obtaining regulatory impact information from impacted regions for significant changes.
- Provides early feedback to Global Operations on planned product and process improvements and communicates early on plans for those changes to the regulatory organization.
- Owns the process of standards management and assures that action items coming from impact assessments are tracked to closure.
- Monitors changes in regulations in the key markets and ensures timely impact assessments are conducted and necessary actions are assigned and tracked to closure.
- Ensures that a register of approved claims per product is maintained and coordinates review of marketing and promotional material
The Successful Applicant
The ideal Senior Regulatory Operations Manager (Medical Device Industry) that we are looking for should have:
- BSc in a related filed - science, engineering, quality, biotechnology or equivalent relevant experience.
- 5 years' working experience in Regulatory Affairs in Medical Device/Pharmaceutical industry,
- Project management skillsAble to assess technical matters on regulatory impact
- Able to resolve conflicts through influencing, negotiations and/or remediation
What's on Offer
Continuous development and career advancement opportunities within the organisation.