Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation ...
Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation ...
Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation ...
Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation ...
International Regulatory Affairs Lead (Medical Devices)
Cupertino, CA ยท On-site
$218.30 - $363.70/hr
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States ... S., EU, APAC, LATAM, ASEAN, and other regions. * Deep expertise in developing global product ...
International Regulatory Affairs Lead (Medical Devices)
Cupertino, CA ยท On-site
$218.30 - $363.70/hr
International Regulatory Affairs Lead (Medical Devices) Cupertino, California, United States ... S., EU, APAC, LATAM, ASEAN, and other regions. * Deep expertise in developing global product ...
... LATAM, ASEAN and other global regulations that affect Class I, II and III devices Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad Significant ...
... LATAM, ASEAN and other global regulations that affect Class I, II and III devices Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad Significant ...
... LATAM, ASEAN and other global regulations that affect Class I, II and III devices Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad Significant ...
... LATAM, ASEAN and other global regulations that affect Class I, II and III devices Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad Significant ...
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)
Long Beach, CA ยท On-site
$107K - $125K/yr
The Senior Regulatory Affairs Specialist for Medical Devices is a key contributor in bringing the ... S., LATAM) and related regulatory activities, ensuring new or updated requirements are effectively ...
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)
Long Beach, CA ยท On-site
$107K - $125K/yr
The Senior Regulatory Affairs Specialist for Medical Devices is a key contributor in bringing the ... S., LATAM) and related regulatory activities, ensuring new or updated requirements are effectively ...
... medical devices and digital health products * Demonstrated success leading FDA Class II 510(k ... S., Canada, LATAM) * Proven ability to make decisions and drive compliance without heavy oversight
Quick apply
... medical devices and digital health products * Demonstrated success leading FDA Class II 510(k ... S., Canada, LATAM) * Proven ability to make decisions and drive compliance without heavy oversight
Supportsregulatory strategy and compliance activities forHydraFacial'saesthetic medical devices and ... S., LATAM) and related regulatory activities, ensuring new or updated requirements are effectively ...
Supportsregulatory strategy and compliance activities forHydraFacial'saesthetic medical devices and ... S., LATAM) and related regulatory activities, ensuring new or updated requirements are effectively ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
Quick apply
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
Quick apply
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
Quick apply
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
... medical devices. You will support the execution of regulatory strategies and drive high-quality submissions across complex international markets, including APAC, MEA, LATAM, and MDSAP-participating ...
The position requires an intermediate understanding of medical devices, their use, and the ... Exposure to regulatory activities in Latin America (LATAM), including understanding of regional ...
Quick apply
The position requires an intermediate understanding of medical devices, their use, and the ... Exposure to regulatory activities in Latin America (LATAM), including understanding of regional ...
Regulatory Affairs and Quality Assurance Specialist
Huntington Beach, CA ยท On-site
$90K - $120K/yr
Our mission is to deliver safe, reliable, and innovative medical devices that improve patient ... S. and international medical device regulations and standards (e.g., Canada, EU, Japan, LATAM)
Regulatory Affairs and Quality Assurance Specialist
Huntington Beach, CA ยท On-site
$90K - $120K/yr
Our mission is to deliver safe, reliable, and innovative medical devices that improve patient ... S. and international medical device regulations and standards (e.g., Canada, EU, Japan, LATAM)
Our mission is to deliver safe, reliable, and innovative medical devices that improve patient ... S. and international medical device regulations and standards (e.g., Canada, EU, Japan, LATAM)
Quick apply
Our mission is to deliver safe, reliable, and innovative medical devices that improve patient ... S. and international medical device regulations and standards (e.g., Canada, EU, Japan, LATAM)
Regulatory Affairs Specialist
Fort Worth, TX ยท On-site
$75K - $90K/yr
... medical devices. This role will play a critical part in supporting product registrations ... Support regulatory activities for international markets including Canada, LATAM, and Asia. * Assist ...
Regulatory Affairs Specialist
Fort Worth, TX ยท On-site
$75K - $90K/yr
... medical devices. This role will play a critical part in supporting product registrations ... Support regulatory activities for international markets including Canada, LATAM, and Asia. * Assist ...
Regulatory Affairs Specialist
$75K - $90K/yr
... medical devices. This role will play a critical part in supporting product registrations ... Support regulatory activities for international markets including Canada, LATAM, and Asia. * Assist ...
Regulatory Affairs Specialist
$75K - $90K/yr
... medical devices. This role will play a critical part in supporting product registrations ... Support regulatory activities for international markets including Canada, LATAM, and Asia. * Assist ...
Medical Device, Product Marketing Manager - ENT
Montvale, NJ ยท On-site
$161K/yr
D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global ... LATAM). This includes responsibility for marketing plans, marketing collateral development ...
Medical Device, Product Marketing Manager - ENT
Montvale, NJ ยท On-site
$161K/yr
D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global ... LATAM). This includes responsibility for marketing plans, marketing collateral development ...
Medical Devices Latam information
See salary details
$12.98 - $14.29
2% of jobs
$14.29 - $15.60
8% of jobs
$15.60 - $16.91
12% of jobs
$17.14 is the 25th percentile. Wages below this are outliers.
$16.91 - $18.23
17% of jobs
The median wage is $19.09 / hr.
$18.23 - $19.54
17% of jobs
$19.54 - $20.85
14% of jobs
$21.47 is the 75th percentile. Wages above this are outliers.
$20.85 - $22.16
12% of jobs
$22.16 - $23.47
7% of jobs
$23.47 - $24.78
5% of jobs
$24.78 - $26.09
4% of jobs
$26.09 - $27.40
2% of jobs
$12
$19
$27
How much do medical devices latam jobs pay per hour?
What is a Medical Devices LATAM specialist?
What are common challenges faced by professionals working in medical devices for the LATAM region?
What skills and qualifications are needed to thrive as a Medical Devices LATAM specialist?
What is the difference between Medical Devices Latam vs Medical Sales Representative?
| Aspect | Medical Devices Latam | Medical Sales Representative |
|---|---|---|
| Certifications | Typically requires industry-specific certifications or degrees in healthcare or biomedical fields | Often requires sales or marketing certifications, with some roles preferring healthcare knowledge |
| Work Environment | Involves technical product knowledge, training, and support within healthcare facilities or offices | Focuses on client meetings, product demonstrations, and sales pitches, often traveling |
| Employer & Industry Usage | Used by medical device companies, hospitals, and healthcare providers in Latin America | Employed by medical device companies, pharmaceutical firms, and sales agencies |
Medical Devices Latam professionals focus on technical support, product knowledge, and industry compliance, while Medical Sales Representatives primarily handle sales, client relationships, and product promotion. Both roles are essential in the healthcare industry but differ in daily tasks and skill requirements.
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Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 25 days ago
Job description
Position Summary:
Under the supervision of the Regional Director, Regulatory Affairs, this role is responsible for supporting the preparation of regulatory 510(k) submissions, Health Canada licenses and assisting international business partners in Latin America, Asia, and Europe with product registrations; preparation of technical files; provide change notifications and registration support to foreign distributors and notified bodies; provide regulatory support to lifecycle management and new product development/new product introduction, Unique Device Identifier GUDID maintenance, on market labeling and submission impact reviews, labeling reviews and adverse event reporting; Yearly Registration of US FDA Establishment License and updates to product listings; Export documentation to support shipping.
Essential Job Functions:
- Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)'s.
- Work with Regional Director, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements.
- Work to support and ensure regulatory compliance across Canada and LATAM region for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics. This includes creation of US FDA Certificates of Foreign Government, legalization of documents and working with cross functional groups to gather technical data.
- Assist with the development of the US, Canadian and LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
- Support and make recommendations for projects by working closely with Canadian and LATAM functional partners to move projects from discovery to launch.
- Under supervision, evaluate proposed product modifications for domestic and international regulatory impact, completing regulatory assessments as needed in change control process.
- Ensure compliance with applicable US, Canadian, Brazilian, Colombian, Mexican and Argentinian regulations and standards.
- Oversee MDR and complaints; submit adverse events to the US FDA and assess impact on other markets.
- Prepare necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Under supervision, prepare responses to health authority questions and other regulatory correspondence.
- Ensuring the maintenance of Regulatory related policies and procedures in quality management system.
- Update and maintain US FDA Establishment Registration and Listing, Health Canada licenses and the GUDID database for Unique Device Identifiers as products are added and discontinued.
- Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
- Review and approve promotional materials and labeling for impact to product classification and 510(k)'s and other licenses impacted.
Other Duties:
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
Education
- BS in Science or Medical / Healthcare related field or higher
Knowledge/Experience
- Minimum of 3 years of related regulatory and Quality experience in US and Canada regulated Medical Devices industry with Class I and II Medical Devices and combination products.
- Authored at least one 510(k) submission in US FDA electronic system. Health Canada licensing submission experience.
- Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, and Europe) including export documentation management is desired .
- Experience with GUDID/UDI and reporting Adverse Events to the US FDA is desired.
- Experience with regulations for Medical Device Software in US.
- Regulatory Affairs Certification is highly desirable.
Skills
- Working knowledge of US FDA and Health Canada Regulatory Authority computerized submission systems
- Excellent written and verbal communication skills
- Proficiency in MS Office applications including Word, Excel, PowerPoint including creation of graphs
- Good interpersonal and organizational skills
Abilities
- Ability to read, interpret and appropriately apply regulations and guidance to support regulatory submission in US, Canada and LATAM regions. Ability to set and meet goals and perform job responsibilities under supervision of the Regional Director, Regulatory Affairs.
What Makes Sunstar Special is:
- A business focused on health and wellness of people around the world
- High Quality Products
- Beautiful state-of-the-art facility
- Diversity and Inclusion
- Corporate Social Responsibility Program and partnership with charitable organization
- Strong value placed on company culture
- Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
- Opportunities for career growth and advancement
- Employee discount on Sunstar products
- 401K retirement plan with employer match (Pretax and Roth options)
- 401K profit sharing contribution based on company performance.
- Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
- Competitive bonus
- On-site cafรฉ
- On Site Fitness Center
- Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
- Holiday Lunches
- Beautifully maintained walking trails
- Hybrid Schedule (certain departments)
- Numerous employee appreciation events throughout the year.
- Recognition and Rewards Programs
- Anniversary, Birthday and New Hire Announcements
If you'd enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.
The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their gender, and race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual.
The pay range for this position of Sr. RA Specialist-Medical Devices is $93,381 - $144,000, However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
About Sunstar
Sourced by ZipRecruiter
Industry
It services
Company size
1,001 - 5,000 Employees
Headquarters location
Palatine, IL, US
Year founded
1932