Regulatory Affairs Specialist ensuring compliance for IVD products. Collaborate with teams to develop regulatory strategies and prepare submissions to FDA and EU authorities.
About the role
- Senior Regulatory Affairs Specialist in Ultrasound focusing on regulatory submissions and product clearances. Collaborating with regulatory authorities to ensure compliance and timely product development.
Responsibilities
- Collaborating with regulatory teams and authorities to secure timely product clearances
- Coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA
- Offering strategic guidance on clinical studies and evaluations
- Serving as the Regulatory Affairs representative for BG Ultrasound
- Providing guidance on regulatory issues related to product development, labeling, and marketing strategies
- Supporting cross-functional teams with regulatory expertise during the design and development phases for new products
- Leading global regulatory intelligence initiatives and contributing to regulatory and product registration strategies
Requirements
- 5+ years of experience in medical device regulatory affairs
- 510(k), and EU MDR Technical Documentation authoring experience required
- Experience with SaMD or SiMD submissions is strongly preferred
- Strong understanding of relevant regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304)
- Experience with software development life cycle, artificial intelligence, data science, and/or software testing is preferred
- Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline
- RAPS certification is a plus
- Must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
- Willing and able to travel up to 10% based on business needs.
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Associate Director Regulatory developing and implementing worldwide regulatory strategies for new products at Grifols. Leading interactions with regulatory authorities and advising cross - functional teams.
Cybersecurity Associate supporting clients in cybersecurity risk management and governance strategies. Involving assessments, policy reviews, and developing security frameworks.
Senior Associate at PwC managing cybersecurity risk, compliance, and governance for clients. Leading security strategy initiatives to protect against cyber threats.
Director leading compliance strategies at Walmart, enhancing operational integrity through tech collaboration and team leadership. Fostering partnerships to uphold ethical standards across the organization.
Manager, Field Compliance supporting US Psychiatry compliance program at Lundbeck. Driving and implementing all elements of Lundbeck US Compliance Program along with field - based teams.
Risk & Compliance Lead overseeing compliance management and statutory requirements at JLL. Leading audits and collaborating with cross - functional teams to mitigate legal risks and ensure compliance.
Senior Regulatory Affairs Analyst at Johnson & Johnson, responsible for ensuring compliance and regulatory strategy in São Paulo. Involves preparation and submission of regulatory dossiers and compliance assurance.
Coordinator for regulatory review assisting with product registration and compliance at e.l.f. Beauty, a leader in clean and cruelty - free cosmetics. Collaboration with cross - functional teams for global product launches.
Junior Compliance Manager supporting the development of a compliance management system at an international financial services company based in Cologne, focusing on digital processes and modern governance tools.