Regulatory Affairs Sr Specialist

Ledgent Technology; United States; Remote; Full time

Job summary

A global leader in life-saving medical devices is seeking a Sr. Regulatory Affairs Specialist for a fully remote position. Responsible for managing regulatory submissions and compliance for products in China and Hongkong, the ideal candidate has a strong background in regulatory affairs with a focus on medical devices. Candidates should have a degree in a scientific field, fluency in Mandarin, and several years of relevant experience.

Qualifications

• Bachelor's degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry).
• 5-7 years of experience preferred, specifically with China regulatory registration.

Responsibilities

• Create regulatory submissions for China and Hongkong products.
• Provide guidance on regulatory strategies and product impact assessments.
• Represent the regulatory function on product development teams.

Skills

Fluency in Mandarin Chinese

Good written and verbal communication

Problem-solving skills

Organizational skills

Analytical skills

Interpersonal relationship skills

Attention to detail

Education

Bachelor's Degree in scientific discipline

Tools

Microsoft Office Suite

Job description

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This range is provided by Ledgent Technology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$48.00/hr - $50.59/hr

Roth Staffing is looking for a Sr. Regulatory Affairs Specialist for our client. This will be a 100% remote role. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.

Job Description:

Summary: The main function of a regulatory affairs specialist is to complete and maintain China and Hongkong regulatory approvals and clearances of assigned products.

Key Responsibilities:

• Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by China and Hongkong affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions
• Participate in providing guidance on strategies and contingency planning with respect to China and Hongkong regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
• Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.
• Other incidental duties assigned by Leadership.

Additional Skills:

• Fluency in Mandarin Chinese
• Coursework, seminars, and/or other formal government and/or trade association training required
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Solid knowledge of new product development systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:

• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience preferred, experience with China regulatory registration required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Medical Practices

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