Source Job

Spain

  • Achieve mandatory Medical Device Regulation certification to maintain European market access.
  • Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
  • Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.

EU MDR QMS CAPA

14 jobs similar to Senior Healthcare Regulatory Specialist (saMD)

Jobs ranked by similarity.

Europe Unlimited PTO 18w maternity 12w paternity

  • Own international regulatory workstreams end-to-end, transforming frameworks into practical guidance.
  • Keep Chainguard compliant while preserving speed and focus.
  • Lead global regulatory matters from first question to final answer, including diligence, submissions.

Chainguard is building the secure-by-default foundation for modern software, and scaling fast to eliminate threats in their software supply chains. They are founded by industry's leading experts and live and breathe the company values; being customer obsessed, having bias for action, don't take themselves too seriously, and trust each other.

$215,000–$280,000/yr
US

The Senior Director, Product Security will define and lead the product security strategy for the medical device portfolio. Key responsibilities include developing and executing a comprehensive product security strategy aligned with business and regulatory objectives. This role requires overseeing end-to-end product security management, ensuring compliance with regulations and standards.

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.

US

  • Build and mature core elements of Rula’s enterprise Compliance Program.
  • Ensure adherence to federal and state healthcare regulatory requirements across Rula’s clinical operations.
  • Lead compliance risk assessments and internal controls; oversee investigations and corrective action processes.

Rula is dedicated to treating the whole person and aims to create a world where mental health is no longer stigmatized. Rula is a remote-first company that is passionate about making a positive impact on the lives of those struggling with mental health issues.

Europe 5w PTO

  • Monitor and interpret industry codes, translating complex code language into clear decision memos and operating guardrails.
  • Ensure settlement integrity by defining how code changes flow into systems and billing rules, maintaining audit trails for settlement logic and compliance evidence.
  • Establish metering policy, setting COP-compliance standards and pre-go-live checks, documenting MSID vs MPAN handling, and defining exception pathways and evidence requirements.

Tem is rebuilding the energy transaction system, making it transparent and fair. They aim to put power back in the hands of people by enabling businesses to buy renewable energy directly. Backed by top-tier VCs such as Atomico and Albion, they’re creating a new category in energy - one that’s local, decentralised, and built on trust.

$56,532–$88,740/yr
Europe

  • Ensure the quality and regulatory compliance of AI-powered SaMD products.
  • Collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance.
  • Maintain and review audit-ready evidence for software/AI development.

Sword Health is an AI health company that provides care programs for multiple conditions, from musculoskeletal, to women’s health, to mental health.

Global

  • Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
  • Provide clear, structured audit documentation and evidence-based conclusions.
  • Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.

Scarlet is authorized by governments to assess and grant market access to medical AIs, enabling innovative technology to reach patients safely and quickly. They are considered the pre-eminent authority on AI medical devices, serving well-resourced and ambitious companies.

Europe

  • Provides regulatory guidance throughout the clinical development life cycle
  • Compile, coordinate and review applications to Regulatory Authorities
  • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

Europe

  • Assist in ensuring compliance with U.S., Canadian, U.K., and European regulations.
  • Review product labels, claims, and descriptions to ensure they meet regulatory standards.
  • Support Amazon-specific compliance requirements, ensuring product listings meet platform regulations.

Unybrands is building the leading next-generation e-commerce platform for micro-brands. They have acquired 30 brands including Pet Care, Personal Care, Home Care, Supplements, Baby & Juvenile, Garden & Outdoor, Sports & Fitness, and Home, Lifestyle Culinary & Arts, and are headquartered in Miami with a global presence.

Europe

  • Own compliance program development and implementation, ensuring the organization meets legal requirements.
  • Act as the AML Compliance Officer (AMLCO) for the EU entity and remain compliant with AML/CTF requirements.
  • Conduct regular reviews of internal compliance policies and procedures, updating them as necessary.

Deel is the all-in-one payroll and HR platform for global teams, built for today’s world with HRIS, payroll, compliance, benefits, and AI-powered tools. As the fastest-growing SaaS company, Deel has a team of 7,000 spanning 100+ countries with a connected and dynamic culture.

Canada

  • Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
  • Implement action plans to achieve timely approval of submissions ensuring compliance
  • Participate in and support project teams to achieve regulatory goals

Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.

Europe

  • Provides regulatory guidance throughout the clinical development life cycle.
  • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
  • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

US

  • Develop, manage, and execute global clinical studies.
  • Ensure timely and budget-compliant trial activities in accordance with quality standards.
  • Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

Europe

  • Acting as the primary subject matter expert for all security and compliance inquiries.
  • Taking end-to-end ownership of certification lifecycles, such as ISO 27001 and Cyber Essentials.
  • Working closely with the GRC team to improve existing programs.

Sword Health is shifting healthcare from human-first to AI-first through its AI Care platform, making world-class healthcare available anytime, anywhere. They have over 1,000 enterprise clients and are backed by 42 clinical studies and over 44 patents.

Europe

  • Refine existing regulatory compliance programs related to third party suppliers.
  • Oversee due diligence and performance monitoring activities for regulatory compliance.
  • Act as a subject matter expert for audit and exam requests.

Jobgether helps partner companies to find the right candidate. They use an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements.