Sr. RA Specialist at Alcon

Taipei, Taiwan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Eye HealthIndustries

Requirements

Extensive experience managing all medical device registrations
Understands specific hospital requirements (UDI, labeling, listing, tender)
Ability to navigate complex TFDA regulations (labeling, recalls, advertisements)
Ability to engage HA (Health Authorities) and local associations
Business acumen and local sensitivity to align regulatory priorities with business needs
Appropriate education and experience to successfully perform the responsibilities/activities of the role
Adherence to GxP regulations, including following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training

Responsibilities

Coordinate regulatory compliance for Alcon's product portfolio
Manage local initiatives and support business requests for product and regulatory information
Participate in cross-functional teams for risk management and produce compliance metrics
Serve as SME for ensuring strong business support from RA, such as acceleration of new product approval/launch and maintenance of current approved products
Support and execute critical projects: license remediation, product changes, RF certification of legacy products
Perform specialized tasks to optimize outcomes and contribute to project goals
Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities for timely approvals
Approve promotional materials, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations
Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
Support products in the medical device families, ensuring adherence to all relevant regulations based on those product families
Maintain approval information in the internal system or database

Skills

Key technologies and capabilities for this role

Regulatory ComplianceMedical Device RegulationsProduct RegistrationsUDILabelingTFDA RegulationsLicense RemediationProduct SubmissionsRenewalsPromotional Material ApprovalRisk Management

Questions & Answers

Common questions about this position

What is the employment type for this Sr. RA Specialist role?

The position is full-time.

Is this Sr. RA Specialist position remote or office-based?

This information is not specified in the job description.

What key experiences are required for the Sr. RA Specialist role?

Extensive experience managing all medical device registrations, understanding hospital requirements like UDI, labeling, listing, and tenders, navigating complex TFDA regulations including labeling, recalls, and advertisements, and engaging health authorities and local associations is required.

What is the company culture like at Alcon?

Alcon fosters an inclusive culture, recognizing contributions and offering opportunities to grow careers, while innovating fearlessly, championing progress, and acting swiftly to impact global eye health.

What makes a strong candidate for the Sr. RA Specialist position?

Candidates with business acumen, local sensitivity to align regulatory priorities with business needs, and experience accelerating product launches and ensuring business continuity stand out.

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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