Regulatory Specialist

Job Description

Epocal, part of Siemens Healthineers, is a leading manufacturer of a clinical Point Of Care (POC) diagnostic product. 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.

Epocal was acquired by Siemens Healthineers in October 2017. As a leading medical technology company, Siemens Healthineers enables healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. 
For more than 100 years, Siemens Healthineers in Canada has helped healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, more than 800 employees in Canada work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.

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Under the direction of the Regulatory Affairs Manager, the Regulatory 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:

• Provides regulatory support for diagnostic product development and commercial diagnostic products 
• Develops regulatory strategies for product development and modification to achieve clearance/approval in US and internationally
• Researches scientific and regulatory information in order to write, edit, and review documents
• Compiles and publishes all material required for submissions, license renewals, and annual registrations 
• Works with governmental regulatory agencies and other third party accrediting bodies 
• Maintains approvals/licenses/authorizations for existing marketing authorizations
• Ensures accuracy of US registration and device listing
• Provides recommendations on labelling, manufacturing, and analytical and clinical study plans for regulatory compliance 
• Reviews validation reports for regulatory submission soundness 
• Assesses product, manufacturing and labelling changes for regulatory reporting impact and compliance to regulations
• Reviews advertising and promotion as required to ensure compliance with product claims
• Develops internal procedures and tools
• Conducts informational or training sessions for stakeholders
• Organizes and maintains hard copy and electronic department files
• Keeps informed of global regulatory information
• Carries out duties in compliance with established business policies
•Demonstrates commitment to the development, implementation and effectiveness of Epocal Quality Management System per ISO, FDA, Health Canada, and other regulatory agencies
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
•Performs other duties and projects as assigned
•Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

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.

Key Contacts:

• 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

Job Demands:

• 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

Physical :
o 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
• 5-7 years’ experience in Regulatory Affairs, within ISO 13485 registered product development and manufacturing environment preferred
• 3 or more years in an IVD or medical device manufacturing environment is preferred
• Strong knowledge of federal regulations

Compliance Experience:

o FDA 21 CFR Part 820 and associated CFR parts (i.e. 801, 803, 806, 810, 812) - required
o ISO13485 - required 
o IVDD (98/79/EC) & CMDR
o 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: Experienced Professional

Job Type: Full-time

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.

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