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Global Regulatory Compliance Lead || Longevity and Health-monitoring platform || Bengaluru

2 months ago

Tiruchirappalli, India MetaMorph Full time

About MetaMorph:

MetaMorph is a 360° HR Advisory firm incubated within Blume Ventures and dedicated to helping startups scale, evolve, and grow. We’ve helped more than 220 startups and multiple hires (and counting), providing them with the platform and opportunities they deserve.


About Our Client:

Our client is a is the world's most advanced metabolic fitness platform. By using glucose and other biomarkers, they are helping people improve their energy levels, lose fat and avoid metabolic disorders.


Job Summary:

1. Regulatory Strategy & Leadership:

 Develop and execute a comprehensive global regulatory compliance strategy for 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.


2. 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.


3. 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.


4. 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.


5. 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.


6. 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 labelling, packaging, and marketing materials to comply with global regulations.


7. 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.


8. 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.


Skills and Qualifications:

 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.


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.

 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.