Regulatory Affairs Specialist

hace 5 días


San José Province, Costa Rica Vision Achievement A tiempo completo

At Vision Achievement, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Costa Rica. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for medical devices.

Job Description

The successful candidate will be responsible for:

  • Planning and leading public training courses and private courses for major clients related to quality system audits, development, deployment, remediation, and/or regulatory affairs activities;
  • Delivering workshops on quality systems planning and implementation, design control, and process validation;
  • Providing expert advice on FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820 and/or relevant EU Directives;
  • Collaborating with cross-functional teams to ensure effective implementation of regulatory requirements;
  • Staying up-to-date with changes in regulatory requirements and providing guidance to stakeholders;
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in Engineering, Science, or life sciences-related field;
  • Experience with medical device or in-vitro device manufacturing, interpretation, and application of codes, regulations, and standards, GMP;
  • Proven track record of delivering high-quality training programs and workshops;
  • Strong knowledge of regulatory requirements for medical devices, including FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820 and/or relevant EU Directives;
  • Excellent communication and interpersonal skills;
  • Ability to work effectively in a team environment, especially when operating remotely.
Compensation

We offer a competitive salary range of $80,000 - $120,000 per year, depending on experience. This is a home-based position, but occasional travel may be required. We also offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application.



  • San José, San José, Costa Rica Kerry A tiempo completo

    About Kerry:Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Our mission is to create healthier, tastier and more sustainable products that are consumed by billions of people across the world.**Key Responsibilities:**Specialist in Regulatory Affairs - high expertise in allergens, GMO, labels,...


  • San José, San José, Costa Rica Boston Scientific Corporation A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to support our team in San José, Costa Rica.About the RoleAs a Regulatory Affairs Intern, you will work closely with our RA Specialists to learn and assist with regulatory activities in Central America. Your responsibilities will include:Supporting RA Specialists with...


  • San José, San José, Costa Rica The Coca-Cola Company A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at The Coca-Cola Company. In this role, you will be responsible for providing expert guidance on regulatory affairs and ensuring compliance with global regulations.


  • San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    Regulatory Affairs Intern RoleOverviewBoston Scientific Corporation is seeking a highly motivated and detail-oriented individual to support our Regulatory Affairs team as an Intern.Key ResponsibilitiesAssist Regulatory Specialists with regulatory activities, including learning about local regulations, processes, and best practices in Central America.Support...


  • San José, San José, Costa Rica Kerry A tiempo completo

    About KerryKerry is a world-leading company in the food, beverage, and pharmaceutical industries. We partner with customers to create healthier, tastier, and more sustainable products consumed by billions of people worldwide.About the RoleThe Global Regulatory Strategist will manage and improve regulatory processes, ensuring efficient delivery solutions and...


  • San José, San José, Costa Rica Ecolab A tiempo completo

    At Ecolab, we are seeking a Regulatory Compliance Specialist to join our team.This role is primarily responsible for classifying chemicals and equipment according to the Harmonized Tariff Schedule. In addition, the assignee will be responsible for assigning global trade regulations to products, such as export control classification numbers, dual use, drug...


  • San José, San José, Costa Rica The Coca-Cola Company A tiempo completo

    We're seeking a seasoned professional to lead our Scientific and Regulatory Affairs efforts in Latin America.As our ideal candidate, you'll bring 7-10 years of experience in the food industry, with a strong background in regulatory affairs and advocacy.Key responsibilities will include:Providing regulatory expertise and guidance to ensure compliance with...


  • San José, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**: **Onsite Location(s)**:San José, 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...


  • San José, San José, Costa Rica The Coca-Cola Company A tiempo completo

    We are seeking a highly experienced Regulatory Affairs expert to join our team at The Coca-Cola Company.About the RoleThis is a key position that requires strong advocacy skills, coupled with an in-depth understanding of regulatory landscapes and risk management strategies.You will be responsible for implementing globally aligned advocacy strategies,...


  • San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    Boston Scientific Corporation OverviewBoston Scientific is a leading medical technology company that prioritizes diversity, equity, and inclusion excellence. Our commitment to innovation and collaboration drives our work forward.Job Summary:This role involves working on novel Atrial Fibrillation technology, Pulsed Field Ablation, and ensuring compliance with...


  • San Francisco, Heredia, Costa Rica Philip Morris International A tiempo completo

    We are building our future on a clear purpose – to deliver a smoke-free future. This transformation brings huge opportunities, and we are looking for a talented individual to drive our Sustainability and Regulatory Affairs strategy in Central America and Caribbean.Main responsibilities include formulating and managing overall sustainability strategy,...

  • Vice President

    hace 2 meses


    San Francisco, Heredia, Costa Rica Moody'S A tiempo completo

    Moody's is a leading provider of credit ratings and research in the financial markets. We are seeking an experienced professional to join our Compliance and Regulatory Affairs team as a Vice President - Compliance and Regulatory Affairs. Based in our global offices, this role will be part of the broader Compliance and Regulatory Affairs team within Moody's...


  • San José, Costa Rica The Coca-Cola Company A tiempo completo

    Are you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry? We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities. If this sounds like you, this role could...

  • Regulatory Specialist

    hace 6 meses


    San José, Costa Rica 360training A tiempo completo

    **360Training** 360training offers a compelling compensation package that ties to performance and impact. We offer quality health plans to meet a variety of needs, life and disability benefits, a retirement savings plan with company match, and a Flexible Time Off program. **Regulatory Specialist** The **Regulatory Specialist** will be responsible for...


  • San José, San José, Costa Rica SAO Fortrea Brazil Limitada A tiempo completo

    Job SummarySAO Fortrea Brazil Limitada is seeking a highly skilled Global Regulatory Submissions Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for overseeing and ensuring the compliance of regulatory submissions, including submission strategy, timeline planning, and delivering to agreed-upon timelines.Key...


  • San José, Costa Rica Pfizer A tiempo completo

    Organizational Relationship(s) - Works closely with local PCO BU teams in country and internal stakeholders - Works closely with above country support as GRA-I LatAm Regional Hub, Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Medical managers and other relevant support areas involved in product registration and product...


  • San José, San José, Costa Rica Mondelez International A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced Strategic Corporate Affairs Director to join our team at Mondelez International in Latin America. As a key member of our corporate affairs team, you will be responsible for developing and executing a comprehensive CGA strategy across multiple markets, leveraging synergies where possible.Key...


  • San José, San José, Costa Rica Pfizer A tiempo completo

    Job DescriptionJob Title: Regulatory Strategy CoordinatorJob SummaryThe Regulatory Strategy Coordinator will play a key role in the planning and execution of regulatory strategies for products submissions and lifecycle management. This includes coordinating activities related to dossier planning and submission, interacting with internal stakeholders, and...


  • San José, Costa Rica Ecolab A tiempo completo

    JOB DESCRIPTION Join Ecolab as an Associate Regulatory Specialist . This position is primarily responsible for classifing chemicals and equipment according to the harmonized tariff nomenclature. In addition, assign global trade regulations to products, such as . export control classification number, dual use, drug precursor and Chemical Weapons Convention...


  • San José, San José, Costa Rica 360Training A tiempo completo

    Regulatory Specialist RoleAt 360Training, we offer a dynamic compensation package that ties to performance and impact. Our benefits include quality health plans, life and disability benefits, a retirement savings plan with company match, and a Flexible Time Off program.Responsibilities and RequirementsDevelop and maintain a system for documenting, tracking,...