Regulatory Affairs Specialist
Are you interested in the biomedical field and medical devices? Do you have prior experience writing and reviewing regulatory documents? Come discover Bodycad’s personalized products and the unique regulatory challenges associated with them!
What is it like to work at Bodycad?
At Bodycad, you will discover:
- A fast-growing company that is revolutionizing the international orthopaedics industry by offering prostheses/products that are 100% personalized to the patients’ needs;
- A team of sharp-minded, curious and passionate specialists that combine the latest technology with completely innovative approaches derived from a multitude of specialities (mechanical engineering, computer-assisted manufacturing, software development) in order to develop truly unique products;
- Regulatory challenges unlike any you have seen until now;
- The satisfaction of knowing that your work has a decisive impact on the quality of life of the patients that choose our products.
What would your typical workweek look like as a regulatory affairs specialist?
You would play a key role in drafting and reviewing the product approval proposals required by various international regulatory authorities (FDA, Health Canada, CE, etc.). More precisely, you would:
- Participate in the development and implementation of the company’s regulatory strategies;
- Collect and synthesize the information required for the proposals, in accordance with international norms specific to the medical device field;
- Collaborate with other departments, namely the R&D team, to draft and/or review documents in which the engineering test results and product mechanisms are explained clearly and concisely.
Have we piqued your curiosity? Would you like to know what type of profile we are looking for?
- University diploma in engineering (mechanical, biomedical, chemical) or in any other pertinent field;
- 5 years of regulatory affairs experience;
- Excellent communication skills in both English and French;
But, more importantly, we are looking for a person:
- Unafraid of change, that strives on taking on new challenges;
- With sharp strategic skills that enable him/her to develop forceful arguments intended for the regulatory authorities;
- Confident is his/her ability to defend the company’s decisions clearly and concisely;
- Who easily understands technical/mechanical information and who can comfortably summarize the technical specificities of our products for the regulatory authorities;
- Who can solve complex problems with his/her strong analytical skills and capability to ascertain the global implications of a situation.
Do you see yourself in the position we have just described?
Do not wait, send us your CV! It might be the first step in your own personal Bodycad adventure: a unique adventure in which you will find stimulating challenges and professional possibilities, as well a work environment that believes in healthy collaboration, having fun at work and doing things differently.