Epocal is a leading manufacturer in the clinical Point Of Care (POC) diagnostic product market. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite results at the patient bedside. This system is now a well-established tool of the medical profession available worldwide. Epocal is committed to delivering high-quality products and services that patients and providers can rely on for consistently accurate and actionable information. We deploy unique innovative technologies that not only transform diagnostic products, but also expand into new platforms and solutions with proven health and economic outcomes.
This position is an 18 month contract.
Under the direction of the Regulatory Affairs Manager, the Regulatory Affairs Technical Specialist is responsible for developing regulatory plans with moderate level of complexity. Ensures regulatory compliance and optimization of quality system procedures relating to the regulatory requirements that affect Epocal, Ottawa and its global business. Interacts with governmental regulatory agencies and other third party accrediting bodies.
Duties and Responsibilities
- Represents Regulatory Affairs on Product Development Core Teams for Point-of-Care (POC) Diagnostics for in vitro diagnostics (IVD) products.
- Plans and prepares regulatory submissions for new product development to meet the requirements for US, EU and Canada (including 510(k)s, Pre-Submissions, Technical Files/STEDS and license applications) and collaborates with Siemens Regulatory affiliates worldwide to ensure country specific requirements are met.
- Supports the regulatory documentation for commercialized products including International registrations, Regulatory Assessments, and 510(k) Note-to-File justifications for product design changes etc.
- Performs review of promotional material and product labeling for regulatory compliance.
- Supports internal and external Quality audits/inspections.
- Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.
- Reports directly to Regulatory Affairs Manager
- Works closely with the Director Quality Assurance, Quality Assurance, QA/R&D/Marketing department
- Regular interaction with corporate Regulatory and global Regulatory agencies
- Process oriented, logical, analytical, meticulous and highly organized
- Effective oral and written communications skills
- Adaptable and willing to take on multiple new tasks and responsibilities
- Ability to work independently and solve problems
- Juggling and prioritizing multiple tasks within a dynamic work environment
- Optimization of the Regulatory processes within the quality system to suit a rapidly growing company
- Conflicting departmental priorities and obstacles to change
- Ensuring compliance while meeting business objectives
- Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives
- Proven ability to work independently to meet rigorous deadlines without a rigidly defined process in place
- Extended periods of sitting/computer use
Skills & Qualifications (Education and Experience)
- University Degree (preferably BSc, BEng or BA) and/or an equivalent combination of education and experience acceptable to Epocal
- 7-10 years’ experience in Regulatory Affairs, within ISO 13485 registered product development and manufacturing environment preferred
- 5 or more years in an IVD or medical device manufacturing environment is preferred
- Strong knowledge of federal regulations
- Compliance Experience:
- FDA 21 CFR Part 820 and associated CFR parts (i.e. 801, 803, 806, 810, 812) - required
- ISO13485 - required
- IVDD (98/79/EC) & CMDR
- IVDR (2017/746) an asset
- Other country medical device regulations
- Computer literate including MS Office (i.e. Word, Excel, PowerPoint, Visio), Flowcharting software, Acrobat, etc.
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Mid-level Professional
Job Type: Full-Time temporary
Siemens is committed to creating a diverse environment and is proud to be an equal opportunity employer. Upon request, Siemens Canada will provide reasonable accommodation for disabilities to support participation of candidates in all aspects of the recruitment process. All qualified applicants will receive consideration for employment.
By submitting personal information to Siemens Canada Limited or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Code available at www.siemens.ca.
Siemens s’engage à créer un environnement diversifié et est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour ce poste.
En transmettant des renseignements personnels à Siemens Canada limitée ou à ses sociétés affiliées, à ses fournisseurs de services ou à ses agents, vous nous autorisez à recueillir, à utiliser et à divulguer ces renseignements aux fins prévues dans notre Code de protection de la confidentialité, que vous pouvez consulter au www.siemens.ca.