Regulatory Affairs Associate

 Published 23 days ago
    
 Portugal
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Sword Health is on a mission to free two billion people from pain as the world’s first and only end-to-end platform to predict, prevent and treat pain. 


Delivering a 62% reduction in pain and a 60% reduction in surgery intent, at Sword, we are using technology to save millions for our 2,500+ enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, General Catalyst, and Khosla Ventures. 


Recognized as a Forbes Best Startup Employer in 2023, this award highlights our focus on being a destination for the best and brightest  talent. Not only have we experienced unprecedented growth since our market debut in 2020,  but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $2 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our impact. 


Joining Sword Health means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.


This is an opportunity for you to make a significant difference on a massive scale as you work alongside 800+ (and growing!) talented colleagues, spanning two continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all.


SUMMARY

Sword Health is a health care company that provides virtual and digital physical therapy. Sword is committed to providing high-quality medical devices (SFW and HW) that improve patient outcome and safety. As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Medical Device Regulatory Affairs Associate to join our dynamic QARA team.


Reporting to the Head of Regulatory, the Regulatory Affairs Associate will play a pivotal role in ensuring the ongoing safety and effectiveness of our medical devices in the market. This position involves monitoring and assessing post-market data, coordinating with cross-functional teams, and maintaining compliance with regulatory requirements. They will collect, analyze, trend and report on safety data to proactively identify potential adverse safety risk or performance trends. The successful candidate will preferably have a good understanding of medical device regulations with focus on EU and US, excellent analytical skills, and the ability to communicate findings effectively.

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Key Responsibilities
  • Post Market Surveillance Activities:
  • Monitor and analyze post-market data, including complaints, adverse events, and product performance feedback.
  • Conduct trend analysis to identify potential safety issues and product improvements.
  • Extract and generate PMS and operational performance data necessary for generating applicable reports.
  • Ensure timely reporting of adverse events to regulatory authorities in compliance with applicable regulations.
  • Contributes to preparation, conduct and resulting actions related to device audits and inspections.
  • Cross-functional collaboration:
  • Collaborate with QARA, and other teams to address post market issues and implement corrective and preventive actions (CAPAs).
  • Work with QARA team to generate PMS, Post Market Clinical Follow-up (PMCF), Periodic Safety Update Report (PSUR)
  • Compliance and documentation:
  • Maintain accurate and up-to-date records of post-market surveillance activities and reports.
  • Risk management:
  • Support risk assessment activities related to post-market surveillance.
  • Contribute to the development of risk mitigation strategies.
  • Continuous improvement:
  • Identify opportunities for process enhancements and contribute to the improvement of PMS procedures.


Skills and Experience
  • Preferred previous experience in the Medical Device industry (or other regulated industry such as Pharma, IVD) 
  • Bachelor’s degree in a technical, scientific, engineering or related field is preferred.
  • Good working knowledge of regulations and industry standards (US, CA and EU markets). 
  • Strong computer skills and previous applications of Google Sheets, Microsoft Office database management, and reporting packages. 
  • Ability to acquire, query and analyze data with focus on detail.
  • Demonstrates accuracy and thoroughness, applies feedback to improve performance, and monitors own work to ensure quality.
  • Excellent problem solving and applied thinking skills.
  • Highly dynamic, motivated and proactive.
  • Team player with ability to successfully interact with representatives from a variety of disciplines within and external to Sword Health. 


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US Sword Benefits:

*Eligibility for Essential benefits: Full-time employees regularly working 25+ hours per week

Comprehensive health, dental and vision insurance 

Equity Shares

401(k)

Discretionary PTO Plan

Parental leave


US Sword Perks:

Flexible working hours

Remote-first Company

Internet Stipend for remote working

Paid Company Holidays

Free Digital Therapist for you and your family


Portugal - Sword Benefits:

Health, dental and vision Insurance

Meal Allowance

Equity Shares


Portugal - Sword Perks:

Remote Work Allowance

Flexible working hours

Work from home

Unlimited Vacation

Snacks and Beverages

English Class

Unlimited access to Coursera Learning Platform



*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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