We're Hiring!

 

Our open roles are listed below. If you’re interested in working with us, please send your resume and cover letter to [email protected].

Role:

We are currently seeking a self-motivated, charismatic individual to join our regulatory affairs team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we’d love to hear from you!

Essential Responsibilities:

  • Assist with regulatory pathways and strategies, premarket FDA, and international regulatory submissions
  • Support post-market surveillance activities and regulatory requirements
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised regulations

Qualifications:

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 5-7 years’ related work experience in the medical device or regulated industry
  • Working knowledge of FDA and other regulatory authorities
  • Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
  • FDA regulatory submission experience (Pre-Submission, 510ks, De Novo, IDEs)
  • International submission experience a plus
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

This position involves all aspects of Regulatory Affairs, including customer consultation, marketing support, design and development support, and post launch surveillance for our customers.

 

Essential Responsibilities:

  • Assist with development and/or revision of Quality System procedures and processes.
  • Assist with internal and supplier audit development, implementation, and execution
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

Qualifications:

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 2+ years’ related work experience in the medical device industry
  • Working knowledge of FDA and other regulatory authorities
  • FDA Regulatory submission experience (Pre-Submission, 510ks, PMAs, IDEs)
  • International submission experience a plus
  • Quality Systems development, implementation, and training experience
  • Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

Essential Responsibilities:

  • Coordinate sales and marketing initiatives.
  • Conduct research to identify potential clients and contacts within each organization.
  • Support client relations and account management activities.
  • Facilitate new client information to accounting and engineering departments.
  • Coordinate client meetings, conferences, and travel arrangements.
  • Assist with special projects, such as proposal development and event marketing.
  • Develop suitable marketing material.
  • Update social media and website content.
  •  

Qualifications:

  • Bachelor’s Degree in Marketing, Business, Communications, or Advertising
  • 1-3 years’ related work experience in the medical device, healthcare, or pharmaceutical industries
  • Solid computer skills, including Excel, PowerPoint, Word, and Outlook/Gmail
  • Experience with marketing automation/CRM solutions (e.g., Pipedrive, Salesforce, Constant Contact, HubSpot).
  • Experience with WordPress or other website providers a plus.
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong analytical, project management, and organizational skills.
  • Resourceful, self-motivated, and able to work autonomously and proactively.
  • Strong problem-solving skills.