Regulatory Affairs Specialist - Medical Device

About ClinChoice

ClinChoice is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our customers. ClinChoice was established in the US in 1995, and has grown to more than 3,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website ClinChoice.com for our company information.

Responsibilities

This position is open to candidates who have a minimum of two years of hands-on experience in Health Canada medical device regulations and have a basic overall understanding of EU MDR medical device regulations and requirements. This position requires a strong team player who can work across various cultures and departments to meet team, company, and client goals and assigned objectives.

Job Duties

• Post market support for local medical device registrations.
• Work with relevant cross functional teams to collect the required documents.
• Ensuring compliance with current good documentation (cGDP) practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
• Preparation and/or review of letters of authorizations, cover letters for registration certificates, declarations, power of attorney, etc., to ensure accuracy, appropriateness and consistency of documents intended for various regulatory submissions.
• Document review of product changes due to EU MDR impact and the management of any required submissions.
• Maintaining tracking tools to ensure up to date information and traceability of all regulatory data/documentation.
• Effectively communicating with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectations.
• Assisting team members in answering inquiries and providing required documents and information utilizing various search tools and systems.
• Providing support to internal and external teams to address various technical inquiries and provide requested information.
• Filing and retrieving documents as directed and per company’s policies and procedures.
• Extracting available documents from the document management databases and operational systems to assist in the preparation of dossiers.
• Participating in group meetings and provide tactical approaches to addressing issues of basic complexity.

Experience/Skills

• Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
• Have good understanding of current Good Documentation Practices in regulatory environment
• Knowledge of ISO13485, EU MDD/MDR, and Health Canada MDEL/MDL applications is required
• Detail oriented with strong critical thinking and analytical skills and keen on producing results
• Must possess excellent written and verbal communication skills
• Strong organizational skills including attention to detail, good planning and communication skills are required
• Minimum of one year of working experience in Medical Device industry specific to Health Canada