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Senior Regulatory Lead

Houston, Texas, United States, Vancouver, British Columbia, Canada

Who We Are 

We’re a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal – to revolutionize healthcare through innovation, collaboration, and commitment to our core values and behaviors.  

About the Opportunity 

Synthesis Health is seeking a Senior Regulatory Lead to oversee regulatory compliance activities across our product portfolio.  This individual will play a key role in ensuring our products meet all applicable medical device regulations and standards globally while helping drive efficient market access for our cutting edge solution. 

Key Responsibilities: 

Regulatory Management 

  • Leads regulatory compliance activities for all medical device products working closely with Product Managers for creation and maintenance of compliant DHF and Technical files. 
  • Manages all medical device establishment registration and medical device product licensing with regulatory authorities ensuring timely filings and compliant status. 
  • Prepare and coordinate content of all pre-market regulatory submissions in all markets, monitor status, drive timely responses, and ensure project deadlines are met. 
  • Review product labelling for compliance and advice on meeting applicable standards 
  • Establish and maintain relationships with authorized representatives  
  • Manages change control process including regulatory classification of new and updated products and notifications of significant changes to regulatory authorities.  
  • Support Complaint Handling Unit 
  • Remains up to date on applicable regulation and standards including FDA (45 CFR 820); Health Canada MDR; UK MDR, EUMDR. 
  • Maintain familiarity with our products and solutions. 
  • Work with Product, Service, and Quality to submit post-market surveillance plans and reports 
  • Provide regulatory support during third-party audits of the QMS 
  • Keep up to date with changes in relevant regulatory changes and guidance. 
  • Train teams on relevant FDA, Health Canada, and EU regulations and guidance. 

Regulatory Strategic Planning 

  • Consult to Product Managers on regulatory strategy given regulatory requirements  
  • Collaborate cross-functionally to strengthen and build programs to ensure compliance with medical device regulations 
  • Analyzes and communicates to senior management any significant proposed, new or changing regulatory requirements and standards impacting the business. 

Training and Communication 

  • Develops and implements trainings to support ongoing compliance. 
  • Educates, trains, advises, and coach employees to ensure effective implementation of policies and procedures underlying software development. 

About the Right Candidate 

You can work in a fast-paced environment and juggle multiple projects with overlapping deadlines.  

Qualifications 

  • Bachelor’s degree in a related field or an equivalent combination of education and experience.  
  • Minimum of three years’ experience working in regulatory affairs function of distributor or medical device manufacturer of Software as Medical Device (SaMD) products and solutions. 
  • Documented experience achieving market approval for software medical devices in US, Canada, UK, and European markets. 
  • Strong working knowledge of Canada Medical Device Regulations SOR/980282; 21 C.F.R. 800; UK MDR; EU MDR. 
  • Knowledge of ISO 13485, ISO 14972, IS) 62304. 
  • Excellent written and verbal communication skills. 
  • Ability to work in a fast-paced environment.  
  • Ability to work with various data management tools (Excel, SharePoint, Atlassian/Jira, etc.)  

Preferred Qualifications 

  • Experience in Radiology. 
  • Experience in post-market surveillance and medical device complaint handling 
  • Familiarity with Software Development Process 
  • Familiarity with ML and AI as used in Healthtech. 
  • Knowledge of radiology medical devices and regulatory requirements.  

You will adhere to our company’s values and behaviors and incorporate them in your interactions with colleagues and customers.  

Values:  

  1. Clinical service first. 2. Collaborate with our customers. 3. Listen, respect, learn. 4. Innovate to excel. 

Behaviors: 

  1. Be nice. 2. Be creative. 3. Be honest. 4. Be helpful. 

Compensation and Benefits 

Synthesis Health practices location based compensation. Candidate’s compensation packages align with the market within their country of origin. Compensation is paid in the currency of the country where the individual is hired. For Canadian applicants, the salary range is $75,000 – $100,000 CAD.   

Other benefits include but not limited to: Medical, Dental, Vision, “Use as needed” vacation policy, and participation in our employee option program. 

Synthesis Health is an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.

 

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