Specialist I, Reg Affairs
hace 2 semanas
Specialist I, Reg Affairs:
- Remote Eligible: Remote Global
- Onsite Location(s): Heredia, H, CR
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
Team Purpose:
The Global Regulatory Affairs Operations is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
This role partners with other functions to bring forward process improvements and efficiencies in the Regulatory Affairs / Product Approvals space.
Key Responsibilities:
Support process and sub-process stewards and process owners for global regulatory processes, responsibilities include the following:
- Collaborate with division and country regulatory affairs to gather information related to filling process gaps and edit opportunities for efficiencies.
- Support regulatory standard operating procedures and work instructions.
- Support assessments for global requirement changes (including standards) and collaborate with crossfunctional partners on changes to the quality system as needed.
- Support CAPA and NCEP correction and solution activities.
- Support regulatory strategy and execution on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions.
Required Qualifications:
- Minimum of a Bachelor's degree or equivalent work experience,
- 02 years' of experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, pharmaceutical industry, or health care industry
Preferred Qualifications:
- Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
- Degree or work experience in a scientific or technical discipline
- Excellent written and oral communication, technical writing and editing skills
- Excellent research and analytical skills
- Ability to support multiple projects simultaneously
- Working knowledge of FDA, EU and/or international medical device regulations
- Ability to read and interpret global regulations and standards
- General understanding of product development process, design controls and quality system regulations
Requisition ID:558230
Job Segment:
Compliance, Regulatory Affairs, Pharmaceutical, Medical Device, PLM, Legal, Science, Healthcare, Management
-
Manager External Affairs Cr
hace 2 semanas
San Francisco, Heredia, Costa Rica Philip Morris International A tiempo completoBe a part of a revolutionary changeAt PMI, we've chosen to do something incredible. We're totally transforming our business - and building our future on one clear purpose - to deliver a smoke-free future.With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the...
-
Risk Specialist I, Vendor Investigations
hace 2 semanas
San Francisco, Heredia, Costa Rica Amzn Support Srvcs Costa Rica A tiempo completoBachelor's Degree in Risk Management, Business, Statistics, Computer Science, or any other quantitative field from an accredited institution. 35 years of relevant professional experience in Risk Management, Fraud Investigations Analytics, Business Intelligence, or a Data Science. Advanced English skills, including excellent business writing. Proficiency with...
-
Customer Care Specialist
hace 2 semanas
San Francisco, Heredia, Costa Rica CSS Corp A tiempo completoJob title: Customer Care SpecialistWork Location: Ultra Park I, La Aurora, Heredia, Costa RicaExperience: More than 1 year of Call Center experienceEducation Qualification: High School CompletionNo of Openings: 200+ openingsRoles and Responsibilities: Leverage your project product knowledge and customer service skills to answer incoming calls, chats, and/or...
-
Senior Associate Deal Operations Specialist
hace 2 semanas
San Francisco, Heredia, Costa Rica Workday A tiempo completoYour work days are brighter here.At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our people...
-
Customer Service Specialist, Wondery
hace 2 semanas
San Francisco, Heredia, Costa Rica Amazon Support Services Costa Rica SRL - B20 A tiempo completoExperience as a B2C Customer Support Specialist or similar Customer Service role in a digital subscription-based business Experience using help desk software and remote support tools, such as Intercom or Zendesk Experience using payment and billing software, such as StripeKey job responsibilities Monitor and respond to app reviews, with responses being...
-
Customer Service Specialist Ii
hace 2 semanas
San Francisco, Heredia, Costa Rica AbbVie A tiempo completoCompany Description**Responsibilities: - Investigate and problem solve for patients experiencing escalated issues such as disadvantaged or complex access, savings card/copay card challenges or non-preferred formulary issues. Where necessary, complete a benefit investigation, contact the HCP and/or patient or potentially the filling pharmacy or payor. Quickly...
-
Senior Specialist, Social Media Campaigns
hace 2 semanas
San Francisco, Heredia, Costa Rica LSEG (London Stock Exchange Group) A tiempo completoSenior Specialist, Social Media Campaigns External titles: Paid Social Campaign Manager, Social Media Campaigns Specialist_We're looking for an individual to provide planning and execution support for paid social media campaigns across the London Stock Exchange Group and its subsidiaries.Reporting into the Senior Manager, Paid Social Media, as part of a...
-
End User Support Specialist Ii
hace 2 semanas
San Francisco, Heredia, Costa Rica TradeStation A tiempo completo#WeAreTradeStationWho We Are: TradeStation is an online brokerage firm seeking to level the playing field for self-directed investors and traders, empowering them to claim their individual financial edge. At TradeStation, we're continuously pushing the boundaries of what's possible, encouraging out-of-the-box thinking and relentless search for...
-
Customer Service Specialist, Wondery
hace 2 semanas
San Francisco, Heredia, Costa Rica Amazon Support Services Costa Rica SRL A tiempo completoExperience as a B2C Customer Support Specialist or similar Customer Service role in a digital subscription-based business Experience using help desk software and remote support tools, such as Intercom or Zendesk Experience using payment and billing software, such as Stripe English level C1 or equivalentKey job responsibilities Monitor and respond to app...
-
Senior Specialist, Marketing, Workflows
hace 2 semanas
San Francisco, Heredia, Costa Rica LSEG (London Stock Exchange Group) A tiempo completoRole OverviewThe Corporate Affairs & Marketing (CAM) organisation acts as a strategic partner to the LSEG business, powering commercial value through an insight led approach that maximises the impact of our investment and our relevance in the market.This role in the Business Marketing team supports the Workflows business, which offers unrivalled data...
-
Senior Specialist, Marketing, Trading
hace 2 semanas
San Francisco, Heredia, Costa Rica LSEG (London Stock Exchange Group) A tiempo completoRole OverviewThe Corporate Affairs & Marketing (CAM) organisation acts as a strategic partner to the LSEG business, powering commercial value through an insight led approach that maximises the impact of our investment and our relevance in the market.This role in the Business Marketing team supports the Trading & Banking business, which offers unrivalled data...
-
Program Communication Experience Senior Specialist
hace 2 semanas
San Francisco, Heredia, Costa Rica DHL A tiempo completoWould you like to be part of the most international company in the world?A company operating in more than 220 countries worldwide and has been pioneering cross-border express shipping since 1969. With over 550,000 employees, we connect people, improving their lives.Discover the spirit of DHL EXPRESS and make your next career move todayCareer opportunities...
-
Finance QA
hace 2 semanas
San Francisco, Heredia, Costa Rica Citi A tiempo completoResponsibilities: Contributes to the design, rollout and governance of financial solutions, including:Participates in formulating and setting strategic direction for the process, organization and architecture covering Finance across Citi businesses, products, functions and locations Assists in setting business and information architecture standards for...
-
Country Support Senior Analyst
hace 2 semanas
San Francisco, Heredia, Costa Rica DHL A tiempo completoWould you like to be part of the most international company in the world?A company operating in more than 220 countries worldwide and has been pioneering cross-border express shipping since 1969. With over 550,000 employees, we connect people, improving their lives.Discover the spirit of DHL EXPRESS and make your next career move todayCareer opportunities...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoCompany DescriptionExperian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best Companies to work for. In addition, for the last five years, we've been named in the 100 "World's...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoCompany DescriptionExperian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best Companies to work for. In addition, for the last five years, we've been named in the 100 "World's...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoCompany DescriptionExperian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best Companies to work for. In addition, for the last five years, we've been named in the 100 "World's...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoCompany DescriptionExperian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best Companies to work for. In addition, for the last five years, we've been named in the 100 "World's...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoCompany DescriptionExperian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best Companies to work for. In addition, for the last five years, we've been named in the 100 "World's...
-
Customer Care Specialist I
hace 2 semanas
San Francisco, Heredia, Costa Rica Experian A tiempo completoFull-timeEmployee Status: RegularRole Type: HybridDepartment: Customer ServiceSchedule: Full TimeCompany Description:Experian is the world's leading global information services company, unlocking the power of data to create more opportunities for consumers, businesses, and society. We are thrilled to share that FORTUNE has named Experian one of the 100 Best...