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Regulatory Affairs Specialist 3 (Finance)

Regulatory Affairs Specialist 3 (Finance)

Company Description
At Intuitive, we are committed to our mission: to enhance lives through minimally invasive care. We leverage ingenuity and advanced technology to empower physicians to heal without constraints.

As a leader in robotic-assisted surgery, we promote an inclusive and diverse team dedicated to making a difference. For over 25 years, we have collaborated with hospitals and healthcare professionals worldwide to tackle healthcare challenges and expand possibilities.

Our company values diversity and inclusion, believing great ideas can come from anyone. We foster a culture of mutual respect and diversity of thought, empowering our team to perform at their best authentically.

Driven by passionate individuals, our culture emphasizes integrity, continuous learning, energy, and diverse experiences to foster innovative thinking. We invest in our teams growth to help them realize their potential and advance our mission.

Join us in making significant progress for healthcare professionals and patients globally. Together, we can advance minimally invasive care.

Job Description

Primary Function of Position

This role partners with the in-country RA team, Product Localization Engineering (PLE), and other cross-functional teams to ensure regulatory activities comply with company policies and relevant regulations, particularly for the China market. Responsibilities include maintaining regulatory filings and licenses, supporting pre-market applications, and post-market compliance tasks.

Essential Job Duties

1. Lead China product registration projects, acting as both 'RA Lead' and 'Project Manager'.
2. Develop regulatory and clinical strategies and establish timelines.
3. Collaborate with JVRA to ensure China regulatory requirements are met for NMPA submissions.
4. Prioritize and coordinate assigned tasks.
5. Support Product Technical Requirement (PTR) drafting and testing arrangements.
6. Write and review sections of regulatory dossiers.
7. Coordinate with JVRA and ISI stakeholders for regulator communications.
8. Maintain trackers for submission deliverables and deficiencies.
9. Manage China Regulatory Project Executive Summaries.
10. Adapt to changing priorities within the China/HK RAQA group.
11. Support department goals and continuous improvement initiatives.
12. Review and approve Good Regulatory Practices (GRAs).
13. Explain local regulatory requirements internally and assist in updating procedures.
14. Support internal and external audits related to China compliance.
15. Assist in China localization projects, such as manufacturing transfers.
16. Work with post-market teams on China Periodic Safety Update Reports (PSUR).
17. Provide guidance to contractors on assigned tasks.

Qualifications

Required Skills and Experience

• Work onsite weekly in Sunnyvale, CA.
• Mandarin Chinese proficiency is required.
• At least 3 years of RA experience.
• Minimum 1 year experience with NMPA medical device regulations and US FDA requirements.
• Experience with complex product development projects.
• Strong communication skills for technical documentation and regulatory submissions.
• Good interpersonal skills for cross-functional collaboration.
• Solid project management skills with regional and cross-functional support experience.
• Commitment to quality and best practices.
• Proficiency in Microsoft Word, Excel, and Project.

Education and Training

• B.S./B.E. or higher in life sciences, biomedical engineering, or related fields.
• Advanced degrees preferred.

Preferred Skills and Experience

• Knowledge of SaMD and SiMD is a plus.
• Experience with RIMS (e.g., Veeva, Rimsys) is a plus.
• Regulatory Affairs Certification (RAC) is desirable.
• Familiarity with SAP, Agile, or similar systems is a plus.

Additional Information

Note: Due to the nature of our business, proof of vaccination may be required.

We are an Equal Opportunity Employer, committed to diversity and inclusion, and prohibit discrimination of any kind.

Mandatory Notices

We consider qualified applicants with arrest and conviction records in accordance with fair chance laws.

Our compensation packages are market-competitive, including base pay, incentives, benefits, and equity. Actual pay depends on experience, skills, and qualifications. Salary ranges:

Region 1: $114,800 - $165,200 USD

Region 2: $97,600 - $140,400 USD

Shift: Day

Workplace: Onsite

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