- Manage project related to the medical device regulations;
- Review and write documents for the submission of the regulation's authorities;
- Ensure regulatory section is taken into account in every aspect of a project;
- Proceed to regulatory surveillance to be aware of any changing in order to reduce non conformity risks;
- Write the standard operating procedures (SOPs) related to regulations;
- Train or participate to the training of the personnel in charge of regulatory process;
- Support by your technical expertise the less experienced personnel;
- Participate to the weekly or monthly meetings about the regulatory cases;
- Provide solutions to problems encountered and perform all tasks relevant to the mandate;
- Bachelor's or Master's degree in sciences (Medical Technology, Chemistry, Biochemistry, Pharmacology, etc), in biomedical engineering or any other related discipline;
- 1 (one) to 10 (ten) years of experience in medical device or pharmaceutical industries;
- Strong project management skills (an asset);
- Experience in regulatory affairs in medical device or pharmaceutical industries (an asset);
- Proven knowledge of ISO 13485 Regulation;
- Proven knowledge of the medical device classes: I, IIa, IIb et III;
- Proven knowledge of Health Canada and FDA Regulations;
- Writing/oral communication skills, English and French;
- Perfect bilingualism (an asset);
- Valid class 5 driver's license (an asset);
- Mobility, willing to travel (an asset).
- Leadership;
- Rigor et discipline;
- (Organize), able to manage several projects;
- Analytical and critical mindset;
- Perseverance;
- Humility.
- Competitive wages;
- Group insurance;
- Professional insurance;
- Remote work, according to the customer needs;
- Vacations: 3 weeks;
- Paid sick leave: 3 days;
- Monthly transportation fees;
- Career advancement opportunity;
- Continuing education.
-
Regulatory Affairs Manager
1 week ago
EightSix Network Quebec City, Canada Part time / Full timeJob Description · Regulatory Affairs Manager · Montreal or Quebec City, Quebec · Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will ...
-
Project Manager Regulatory Affairs
1 week ago
CIMA Canada Inc Québec, QC, CanadaAt CIMA+, you'll find a place where you'll have many opportunities to learn and develop while working on engaging projects. · You will have the flexibility to manage your work on your own terms and define what work-life balance means to you. · The Project Director's main role i ...
-
Protocol Labeling Strategist
1 week ago
EightSix Network Quebec City, Canada Part time / Full timeJob Description · Are you ready to take your career to the next level in the exciting world of pharmaceutical regulatory sciences? Our esteemed company is seeking a highly skilled and motivated Protocol Labeling Strategist (Manager) to join our Global Regulatory Sciences team. T ...
-
Syneos Health Quebec City, CanadaDescription · Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. · Every day we perfor ...
-
Medical Science Liasion
2 weeks ago
Alexion Pharmaceuticals Québec City, Canada Full timeMedical Science Liaison (Hematology/Nephrology) – Quebec/Atlantic · Location: · Quebec/Atlantic (Field Based Role) · Reports To: · Medical Director, Medical Affairs Canada · This is what you will do: · The Medical Science Liaison (MSL) is field based scientific expert that st ...
-
Stryker Québec City, Canada Full timeWhy join Stryker? · We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting · Our total rewards package offering includes bonuses, healthcare, insurance benefits, ...
-
BMO Québec City, CanadaApplication Deadline: · 08/04/2024 · Address: · VIRTUAL61 - HomeRes - QC - BMO · #B2COperationsPlease note that the selected candidate will have to come to the Montreal office twice per month. · Analyzes new customer credit applications. Makes credit decisions / recommendations ...
-
Key Account Manager
1 week ago
EightSix Network Quebec City, Canada Part time / Full timeJob Description · Job title: Bilingual Key Account Manager - Ingredients (industrial clients) · Location: Rue Saint-Jacques, Montreal, H4B 1W4 (hybrid face-to-face and telework + travel in Quebec and Ontario to meet customers) · About Lactalis Canada · Welcome to Lactalis Can ...
-
Lead or Senior Lead, Social Performance
2 weeks ago
Wesdome Gold Mines Ltd. Québec, QC, CanadaWesdome Gold Mines has had over 30 years of continuous gold mining operations in Canada. The Company is 100% Canadian focused with a pipeline of projects in various stages of development. The Company's strategy is to build Canada's next intermediate gold producer, producing 200,0 ...
-
Notified Québec, QC, Canada $25Notified, a segment of West Technology Group, is hiring a Bilingual (EN/FR) Proofreader. The Proofreader will be required to be fluent in both English & French. Please submit your resume in English. Location: This position will be located in our office in Toronto, Canada, Chicago ...
-
Stryker Group Québec, QC, CanadaWhy join Stryker? · We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting · Our total rewards package offering includes bonuses, healthcare, insurance benefits, ...
-
Legal Counsel, Commercial Law
2 weeks ago
Optel Group Québec, QC, CanadaA certified B Corp company, Optel is one of the largest providers of traceability systems in the world. Its mission: to use its innovative technologies to create a better world through responsible capitalism. The company's renowned solutions guarantee the quality of healthcare pr ...
-
Clinical Educator
4 weeks ago
Olympus Corporation of the Americas Québec, CanadaAre you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. · **_Let's inspire healthier lives, together._** · Olympus Canada Inc. (OCI) distributes a wide rang ...
-
Medical Science Liasion
13 hours ago
AstraZeneca Quebec City, Canada**Medical Science Liaison (Hematology/Nephrology) - Quebec/Atlantic** · **Location**: · Quebec/Atlantic (Field Based Role) · **Reports To**: · Medical Director, Medical Affairs Canada · **This is what you will do**: · The Medical Science Liaison (MSL) is field based scientific ex ...
-
iA Groupe financier / iA Financial Group Quebec City, CanadaCorporate and Transactional Affairs/Permanent position/Telework or hybrid_ · Would you like to join an exciting, rapidly growing company? Our legal team is evolving. Join us · We are looking for an experienced legal advisor to complete the team that provides legal support to the ...
-
Clinical Operations Manager-1
2 weeks ago
Parexel Quebec City, Canada**Job Title: Clinical Operations Manager (COM/COM-F/COM-R)** · **Position Purpose**: · The Clinical Operations Manager (COM/COM-F/COM-R) is responsible for the following: · - Performance and compliance for assigned protocols in a country in compliance with International Committee ...
-
Logistics and Customs Compliance Specialist
3 days ago
Eddyfi Technologies Quebec City, Canada**Your daily life**: · Are you ready for a challenge in the world of high technology? We would be thrilled to have you on board Eddyfi Technologies is seeking an International Logistics Specialist to join the team. · **In this role you will**: · As a key resource, you will be the ...
-
Clinical Research Manager
2 weeks ago
Labcorp Québec, Canada**Clinical Research Manager** · **Home-Based in Montreal, Quebec** · **Why settle for one thing when you can have everything?** · Labcorp Drug Development gives you the best **two-for-one** opportunity for career growth. Who doesn't want twice the perks? Working at one of the lar ...
-
International Logistics Specialist
1 week ago
Eddyfi Technologies Quebec City, Canada**JOB TITLE**: International Logistics Specialist · **REPORTS TO**: Director, Procurement and Logistics · **DIVISION**: Head Office in Quebec · **Your daily life**: · Are you ready for a challenge in the world of high technology? We would be thrilled to have you on board Eddyfi T ...
-
Analyst, Legal and Regulatory Compliance
2 weeks ago
Desjardins Québec, CanadaAs a legal and regulatory compliance analyst, you help design, institute and coordinate the compliance framework and enforce related rules. You help ensure that oversight measures such as officer and employee behaviours comply with the organization's standards. You analyze and he ...
Specialist/Project Manager, regulatory affairs - Québec, QC, Canada - Fopconsultants
Description
Brief description of the position :
In order to meet the needs of our customers in the Medical Devices sector, we are looking for regulatory affairs consultants to carry out various mandates. The main missions would be to support all of the different departments in their regulatory requirements process, participate in staff training regarding regulatory instructions, write documents for the regulations authorities and collaborate on any project involved in medical device regulation.
Main responsibilities:
Without limitation, the main tasks involve:
Qualifications:
Personal skills:
What we offer :
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:
