Regulatory & Scientific Affairs

Clinical Regulatory Affairs Associate

Mississauga, Ontario Req.Id.: 10889


Description

Position at Baylis Medical

Please note that this is a 1-year contract position.

Overview:

Assists the Clinical Evaluation Report Lead in clinical, regulatory and scientific affairs activities.

Snapshot of Responsibilities: 

  • Conduct systematic literature reviews as per Baylis procedures
  • Collect qualitative and quantitative clinical data from published literature and unpublished reports
  • Critically evaluate published literature and post-marketing data (clinical case reports, sales, complaints etc.) to identify applicable safety and performance and off label trends
  • Assist with literature review / clinical evaluation protocols and reports writing
  • Assist with updating clinical procedure, protocol and report templates as per the regulations and guidelines
  • Assist in keeping abreast of current requirements and guidelines related to clinical evaluations
  • Provides project management support as required
  • Liaise and develop positive relationships with internal and external customers
  • Assist with other regulatory, scientific affairs and post-marketing activities as required
  • Travel as required (occasional)
  • Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures.
  • Other duties as required.
What you bring to the team: 
  • Masters or PhD in life sciences or related field with experience in literature reviews
  • 1-3 years experience in collection, analysis, and critical appraisal of the clinical data
  • Ability to write systematic literature review or clinical protocols and reports
  • Knowledgeable in using PubMed, Google Scholar, EMBASE or similar literature search databases
  • Experience in field related to regulatory affairs/clinical research or post-graduate certificate training in regulatory affairs/clinical research is an asset
  • Knowledge of Canadian, US, and EU regulations and guidelines for medical devices, specifically clinical evaluation requirements are an asset
  • Experience in cardiovascular devices is an asset
  • 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
  • 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.
  • 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.
  • Well-being initiatives, including onsite gym facility and fitness classes (yoga and boot camp).
  • Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.

​​​About Us

At Baylis Medical, everyone works with a shared purpose: to improve the lives of people around the world. Named one of Canada’s Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology. Our focus is on providing physicians clinically-relevant tools, so that no patient goes untreated.

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

Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. 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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