Senior Specialist, RA & QA

Singapore; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Regulatory Affairs Specialist to enhance the regulatory landscape for medical devices. This role involves developing regulatory strategies, preparing submission documents, and ensuring compliance with local and international regulations. Join a dedicated team focused on improving patient outcomes and advancing vital organ therapies. With a commitment to innovation, this position offers a unique opportunity to contribute significantly to the healthcare industry while working in a collaborative environment that values courage and excellence.

Qualifications

• 4+ years of experience in the medical device industry.
• Registered pharmacist with the Singapore Pharmacy Council is a plus.

Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Prepare and submit registration documents for timely approvals.
• Collaborate with teams to ensure regulatory compliance.

Skills

Regulatory strategy development

Communication skills

Negotiation skills

Multitasking

Team-oriented attitude

Education

B.Sc. or B-Pharm

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Essential Duties and Responsibilities:

1. Develop and implement regulatory strategies for medical devices and therapeutic products.
2. Prepare, compile, and submit registration documents, variations, change notifications, and renewals to ensure timely approvals.
3. Ensure product labeling complies with the Company Core Data Sheet and country-specific regulations.
4. Manage databases and reports to ensure information accuracy and maintain regulatory files according to requirements.
5. Monitor the regulatory status of approved products, ensuring files are current and compliance is maintained, and evaluate the impact of amendments or changes to take appropriate regulatory actions.
6. Collaborate with cross-functional teams to ensure regulatory compliance and market continuity.
7. Serve as the key contact for regulatory affairs and be the regulatory knowledge resource for the team.
8. Communicate and negotiate with regulatory agencies to support submissions and projects.
9. Manage change controls and develop strategies to support implementation of local or global changes.
10. Assist in implementing quality systems procedures and participate in activities such as audits, complaint handling, field actions, post-market surveillance, and change control.
11. Support quality operations related to Field Actions, including customer notifications, product holds, and recalls.
12. Assist in product release processes.

Qualifications:

1. Experience with new registration, license extensions, variations, and renewals in the medical device industry; pharmaceutical registration experience is a plus.
2. Effective communication, negotiation, and persuasion skills.
3. Ability to multitask in a fast-paced environment and meet tight deadlines.
4. Flexibility and adaptability to change.
5. Team-oriented and self-motivated attitude.

Education and/or Experience:

1. B.Sc. or B-Pharm (preferred).
2. At least 4 years of relevant experience in the medical device industry.
3. Pharmaceutical registration experience is advantageous.
4. Registered pharmacist with the Singapore Pharmacy Council is a plus.

Reasonable Accommodation

Vantive is committed to providing reasonable accommodations for individuals with disabilities. If you require accommodations during the application or interview process due to a medical condition or disability, please click here to let us know your request and contact information.

Recruitment Fraud Notice

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Address: 2 Woodlands Industrial Park D Street 2, Singapore 737778, Singapore