Head of Quality & Regulatory Affairs
Legal, Quality Assurance
Posted on Wednesday, April 12, 2023
WHO WE ARE
Each year, 2 billion people across the world are limited by physical pain. By helping people live without pain, they are free to do the things they love most with the people they love—and never miss a moment. This is what we do. We create and design new technologies to solve one of the biggest problems in healthcare: taking care of our Physical Health. Sword Health is the world’s fastest growing digital musculoskeletal (MSK) care provider on a bold mission to free two billion people from acute, chronic, and post-surgical physical pain. Our customers include some of the most progressive Fortune 100 and 500 companies, as well as over +1400 other established businesses across the world.
The Sword program allows members to complete a personalized physical therapy program from the comfort of home, with continued support and supervision from one of our talented Sword specialists. Sword’s personalized care is more effective than traditional standards of care, and has proven to deliver best-in-class clinical results. Since breaking into the market less than three years ago, Sword has worked with insurers, health systems, and employers in the U.S., Canada, Europe, and Australia to make high quality musculoskeletal care accessible to everyone.
This is an opportunity to join Sword during a time of hyper growth and expansion. After our recent $2bn valuation, we’re excited to continue accelerating our impact by scaling with high caliber people with passion, commitment and energy to create and deliver technologies, services and products that drive human progress forward.
We welcome you to join our mission, to make a difference on a grand scale and play a pivotal role with a global team at Sword– working alongside great people pioneering novel products and cutting edge technologies.
About the Clinical & Regulatory Affairs team
The Clinical & Regulatory Affairs team is a multidisciplinary team that is responsible for the Clinical Research efforts within the company, as well as for supporting the Marketing, Sales, Customer Success, Clinical Operations, and Clinical Development teams. We are also responsible for ensuring Regulatory and Quality Compliance with our medical devices.
To Do What:
Lead the Quality and Regulatory Affairs team at Sword, with a particular focus on medical device Regulatory aspects.
Our ideal candidate has:
Extensive (10+ years) of experience in regulatory affairs within the medical device industry (particularly SaMD; not Pharma or healthcare providers) in multiple jurisdictions, and is able to define a strategic plan to achieve the desired outcome taking into account the needs and directions of the company.
• Provide guidance on regulatory issues to internal and external stakeholders, namely through the development of regulatory strategies on existing and new products
• Review and approve regulatory submissions
• Ensure timely submission of regulatory filings and responses to regulatory agency requests
• Participate in regulatory agency meetings and negotiations
• Monitor and assess changes in regulatory requirements and communicate impact to relevant stakeholders
• Establish and maintain relationships with regulatory authorities
• Assist in the management of the Quality Management team
• Facilitate the development and implementation of the Quality Management System
• Participate in the development and implementation of strategies to improve overall quality and efficiency
• Facilitate the development and implementation of training programs to enhance quality awareness and compliance
• Monitor and analyze quality performance metrics to identify trends and areas for improvement
• Assist in the scheduling, implementation and monitoring of internal audits.
Our ideal candidate has:
• Extensive (10+ years) of experience in regulatory affairs in multiple jurisdictions, and is able to define a strategic plan to achieve the desired outcome taking into account the needs and directions of the company
• Built(or helped build), grown and led Quality and Regulatory Affairs teams
• Worked in a very fast-paced and fast-changing environment, and has delivered at speed and with quality
• Very strong interpersonal skills and the ability to inspire, motivate and lead, forging strong relationships with and within the team
US Sword Benefits:
Comprehensive health, dental and vision insurance
Discretionary PTO Plan
US Sword Perks:
Flexible working hours
Internet Stipend for remote working
Paid Company Holidays
Free Digital Therapist for you and your family
Portugal - Sword Benefits:
Health, dental and vision Insurance
Portugal - Sword Perks:
Remote Work Allowance
Flexible working hours
Work from home
Snacks and Beverages
*US Applicants Only: Applicants must have a legal right to work in the United States, and immigration or work visa sponsorship will not be provided.*
SWORD Health, which includes SWORD Health, Inc. and Sword Health Professionals (consisting of Sword Health Care Providers, P.A., SWORD Health Care Providers of NJ, P.C., SWORD Health Care Physical Therapy Providers of CA, P.C.*) complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.
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