About Us:
Ultrahuman is a cutting-edge company that develops smart health and fitness wearables and non-wearable technology/devices, helping users monitor and improve their health and general wellness. Our products are designed to seamlessly integrate into everyday life while maintaining high standards of quality, privacy, and safety. We're seeking an experienced Global Regulatory Compliance Lead to oversee regulatory requirements and ensure compliance across all markets.
Job Summary:
As the Global Regulatory Compliance Lead, you will be responsible for ensuring that all Ultrahuman products meet global regulatory requirements. This includes overseeing compliance with international laws and regulations related to healthcare, medical devices, consumer electronics, data privacy, and product safety standards. You will lead a team to manage regulatory filings, obtain necessary certifications, and maintain relationships with regulatory bodies globally.
You will work closely with product development, quality assurance, legal, sales and marketing teams to ensure that compliance is built into the design, development, and launch phases of each product. Your expertise will be key in navigating complex regulatory landscapes, ensuring risk management, and ensuring product success in multiple jurisdictions.
Key Responsibilities:
Regulatory Strategy & Leadership:
- Develop and execute a comprehensive global regulatory compliance strategy for Ultrahuman products.
- Ensure compliance with relevant international standards and regulations (FDA, CE, UKCA, MDR, WEEE, RoHS, FCC, etc.) across various jurisdictions (US, EU, APAC, etc.).
- Stay updated on regulatory changes and assess their impact on the company’s product pipeline and operational processes.
- Publish monthly compliance report to leadership showing compliance status of submissions and approvals; proactively identify & highlight risk areas with proposed solutions for risk mitigation.
Regulatory Approvals:
- Lead the submission of regulatory applications for new products, including working with local and international health authorities, if applicable, and ensuring timely product approvals.
- Oversee all product certifications and registrations required for global market entry (e.g., FDA 510(k), CE Marking, MHRA/MHA approvals, etc).
- Manage regulatory requirements for medical and wellness device classification to avoid legal or compliance risks.
Cross-functional Collaboration:
- Collaborate with product development, legal, and quality assurance teams to ensure product design and development meet all regulatory and compliance requirements from inception.
- Partner with legal and R&D teams to define whether products should be classified as medical devices or general wellness, depending on the jurisdictions.
- Serve as a key advisor to leadership on regulatory risks and product launch implications.
Quality Management:
- Ensure the establishment and maintenance of Quality Management Systems (QMS) aligned with ISO 13485, FDA, and other applicable standards.
- Monitor post-market surveillance requirements, manage risk, and oversee recalls or corrective actions if necessary.
Data Privacy & Security:
- Ensure compliance with global data protection and privacy laws (GDPR, HIPAA, CCPA, etc.), especially regarding health-related data collected through wearables.
- Work closely with the data security and legal teams to ensure robust cybersecurity measures and safeguard consumer data.
Regulatory Documentation:
- Oversee the preparation, filing, and maintenance of regulatory submissions and records, ensuring documentation is accurate, complete, and submitted on time.
- Lead the preparation of product labeling, packaging, and marketing materials to comply with global regulations.
Regulatory Audits & Inspections:
- Lead internal and external audits, manage communications with regulatory authorities, and ensure audit readiness across the organization.
- Respond to regulatory inquiries, investigations, and corrective action requests.
- Assist customer support teams to respond to customer queries in respect applicable product regulations and how we are complying as a Company.
Team Management:
- Lead and mentor the global regulatory compliance team, setting clear goals and providing support for professional development.
- Liaise with external local consultants.
- Establish key performance indicators (KPIs) to monitor compliance effectiveness across regions and teams.
Qualifications:
Experience: 12+ years of experience in global regulatory affairs, preferably in medical devices, healthcare wearables, or consumer electronics.
Knowledge:
- Strong understanding of regulatory frameworks including FDA (Class I, II, III devices), EU MDR, CDSCO, MOHAP, etc.
- In-depth knowledge of GDPR, CCPA, HIPAA, and data privacy standards.
- Experience navigating both wellness and medical device regulations across various geographies.
Skills:
- Leadership & Management: Proven ability to lead and manage global teams with a focus on driving regulatory strategy and compliance.
- Analytical & Problem-Solving: Ability to assess regulatory risks and devise mitigation strategies.
- Communication: Strong verbal and written communication skills to effectively liaise with internal and external teams, regulatory authorities, and external stakeholders.
- Attention to Detail: Meticulous attention to regulatory documentation, submission accuracy, and compliance with varying global standards.
- Adaptability: Ability to manage regulatory complexities in an evolving industry like health tech, balancing innovation with compliance.
- Project Management: Experience managing regulatory timelines, submissions, and audits while coordinating across teams.
Additional Preferred Qualifications:
- Previous experience in regulatory compliance related to wearable technology and IoT.
- Familiarity with AI/ML regulatory guidelines, especially concerning health monitoring algorithms.
- Prior involvement in developing general wellness products that straddle the line between medical devices and general wellness consumer electronics.
Why Join Us:
At Ultrahuman, you will have the opportunity to work at the cutting edge of health technology, where we are redefining how people monitor their health and wellness. Your work will directly impact our ability to provide innovative products that meet regulatory standards across the globe, ensuring we continue to deliver the highest quality, safest products to our users.
Cultural Fit:
We are seeking a candidate who not only shares our vision of creating a healthier future but also demonstrates the dedication to go above and beyond to achieve it. Our ideal candidate is passionate about making a meaningful impact in the health and wellness space, thrives in a fast-paced startup environment, and is willing to take on challenges with a proactive and innovative mindset. In this dynamic and high-growth environment, adaptability, resilience, and a strong sense of ownership are crucial.
As part of a global team, you should possess excellent communication skills, a collaborative spirit, and the ability to work effectively across diverse teams and geographies. We value integrity, accountability, and a commitment to compliance, and we expect our Regulatory Lead to exemplify these values while driving the company's success. A strong work ethic, coupled with a deep dedication to the mission and a readiness to embrace the startup culture, is essential.
What We Offer:
- Competitive salary and benefits, commensurate with experience.
- Opportunity to be a part of a fast-growing, innovative company at the forefront of health and fitness technology.
- Collaborative and inclusive company culture focused on wellness and growth.