Senior Regulatory Affairs Specialist

Type d’emploi: Contractuel
Candidats BioFin prêtsᴹᶜ acceptés : Oui
Catégorie: Direction générale, exploitation et administration
Employeur : Synaptive Medical
Salaire :
Lieu : Toronto, ON
Date de publication : 12 juillet 2019
Date de fin : 11 août 2019

The Opportunity         

Synaptive is seeking a qualified person to support growth of its product portfolio in global markets especially the European Union.  The Regulatory Affairs Specialist will assist the Director of Regulatory Affairs in providing regulatory support for compliance with the new Medical Device Regulations in the EU. You will also liaise with international partners for submission compilation activities in other markets, maintain current registrations and submit documentation on schedule as directed. This is a hands-on role that may require you to roll up your sleeves from time to time and be a supportive team member.  We need individuals who will feel comfortable in a fast-paced environment.

What You’ll Do         

  • Provide support in preparing technical documentation for the EU MDR implementation
  • Assist with writing sections of 510(k)
  • Coordinate and assist in the preparation, compilation and submission of regulatory applications for product approvals domestically and internationally
  • Write design dossiers in STED and CSTD format for complex Class II and III medical devices
  • Participate in product development team meetings
  • Draft sections of DHF and work closely with the R&D and product management teams to provide input on DHF documentation
  • Review submission materials including labeling and technical documentation, etc. for errors prior to submission
  • Conduct change assessments for updates to regulatory cleared products to determine filing needs
  • Assist in responding to requests for additional information from regulatory authorities
  • Assist with creating change orders for the Regulatory department
  • Maintain and update global product listings, facility and establishment registrations
  • Conduct post market surveillance activities on existing and new products
  • Update clinical evaluation reports
  • Participate in quality systems audits as a regulatory SME as required
  • Review, write and contribute toward departmental SOPs and policies
  • Provide support with day to day departmental activities as required

What You’ll Need

  • Electrical, Systems, Chemical or Biomedical Engineering, Life Sciences degree or equivalent. Advanced degree preferred.
  • 3-7 years of medical device regulatory experience
  • Submission writing experience

It’d Be Amazing If You Had

  • Prior CE marking experience
  • Complex submission writing experience such as 510(k), Health Canada license application, design dossiers in STED and CSTD format
  • Familiarity with FDA’s medical device regulations, SOR/98-282, EU MDR, ISO standards, etc.
  • Past experience with Medical Device Navigation Software, instruments and/or surgical tools

About You

  • Friendly and positive attitude
  • Excellent written communication skills
  • Self-motivated and self-managing
  • Excellent attention to detail
  • Ability to work in a highly technical, fast-paced environment
  • Ability to take ownership of a problem and see it through resolution
  • Ability to communicate clearly and effectively with technical team members in order to capture and document various regulatory submission materials such as technical files and 510k documentation
  • Ability to distill complex concepts into clear messaging clear and concise written and verbal communication skills

The Fine Print

The employee may perform other related duties as necessary to meet the ongoing needs of the organization. Synaptive Medical is an equal opportunity employer and welcomes applications from all qualified individuals, including visible minorities, Indigenous People, and persons with disabilities.

We would like to thank everyone who submits a resume for these positions. Due to the volume that we receive, only those candidates selected for interviews will be contacted.

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