Overview:

Reporting to the Director of Regulatory & Scientific Affairs, the Scientific Affairs Associate will support the Regulatory & Scientific Affairs team in regulatory and scientific affairs activities.

Snapshot of Responsibilities:

• Assist in development and execution of clinical evidence development plans
• Assist with collecting and transcribing study data into study database
• Analyze clinical data towards the creation of appropriate device claims and indications
• Assist in the design, initiation, and management of clinical trials for Baylis Medical Technologies devices
• Keep abreast of current clinical literature in fields relevant to Baylis Medical Technologies devices and search out, review, and maintain records for post-market clinical follow-up
• Prepare clinical reports, scientific abstracts, posters and publications related to Baylis Medical Technologies devices
• Provides project management support as required
• Maintenance of scientific affairs documentation to meet applicable standards and regulations
• Liaise and develop positive relationships with internal and external customers
• Assist with other regulatory & scientific affairs activities as required
• Travel as required (occasional)

What you bring to the team:

• Bachelors Degree in life sciences or related field
• One to two years experience in field related to regulatory affairs/clinical research or post-graduate certificate training in regulatory affairs/clinical research
• Previous experience working in the healthcare, medical device or pharma industry preferred.
• Previous experience with Clinical Literature Databases such as Pubmed, Embase or ENDnote or similar software is required.
• Sound knowledge of Canadian, US, and EU regulations and guidelines for medical devices and clinical trials requirements including GCP, ICH guidelines, and ISO 14155
• Exceptional communication and organizational skills
• Attention to accuracy, detail and deadlines
• Microsoft Office and Internet skills
• Ability to manage multiple priorities in a fast-paced environment
• Capable of working individually and/or in a team setting
• Ability to adapt and be flexible
• Positive attitude and excellent interpersonal skills
• Willingness to travel occasionally

What we have to offer:

• Smart commute options including complimentary shuttle from Kipling Station, and subsidized transit program.

• Hybrid Work Model & Flexible working hours that complement core business hours.
• One day off for volunteering, to give back to a charitable organization of your choice.
• Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
• Comprehensive total rewards package, including tuition reimbursement and lifestyle and health spending account.
• Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.

About Us

Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and neurosurgery. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.

We are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make an impact in the lives of patients. Are you ready to join us?

Baylis Medical Technologies is an equal opportunity employer. We are committed to providing a diverse and inclusive work environment, while providing ongoing education for all employees. Qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We firmly believe that our differences make us stronger.

Please inform us if you require any accommodations during the recruitment process.

While we thank all applicants, only those being considered for an interview will be contacted.

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