Specialist/Project Manager, regulatory affairs
1 week ago
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:
- 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.
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:
- 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.
-
Senior Regulatory Affairs Associate
Found in: beBee S CA - 3 weeks ago
Quebec, Canada Parexel Full timeAt Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients. We are seeking a Senior Regulatory Affairs Associate to join our team. As a Senior Regulatory Affairs Associate, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing difference to...
-
Sr project specialist
1 day ago
Quebec, Canada Syneos Health Full timeDescription Senior Project Specialist - Burlington, Canada (Hybrid work schedule) 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. Our Clinical Development model...
-
Sr project specialist
1 day ago
Quebec, Canada Syneos Health Full timeDescription Senior Project Specialist - Burlington, Canada (Hybrid work schedule) 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. Our Clinical Development model...
-
Sr Project Specialist
Found in: Whatjobs CA C2 - 3 days ago
Quebec City, Canada Syneos Health Full timeDescription Senior Project Specialist - Ontario, Canada 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. Our Clinical Development model brings the customer...
-
Sr Project Specialist
Found in: Jobillico Premium CA C2 - 2 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior Project Specialist - Ontario, Canada 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. Our Clinical Development model brings the customer and the...
-
Sr Project Specialist
Found in: Jobillico Premium CA C2 - 1 week ago
Quebec City, Canada Syneos Health Full timeDescription Senior Project Specialist This role is hybrid - requiring 50% time in the Burlington, Ontario office. 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....
-
Sr Project Specialist
Found in: Jobillico Premium CA C2 - 5 days ago
Quebec City, Canada Syneos Health Full timeDescription Senior Project Specialist - Burlington, Canada (Hybrid work schedule) 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. Our Clinical Development model...
-
Sr Project Specialist
Found in: Adzuna CA C2 - 5 days ago
Quebec City, QC, Québec, Canada Syneos Health Full timeDescription Senior Project Specialist - Ontario, Canada 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. Our Clinical Development model brings the customer and the...
-
Sr Project Specialist
Found in: Adzuna CA C2 - 5 days ago
Quebec City, QC, Québec, Canada Syneos Health Full timeDescription Senior Project Specialist - Burlington, Canada (Hybrid work schedule) 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. Our Clinical Development model...
-
Sr Project Specialist
Found in: Adzuna CA C2 - 5 days ago
Quebec City, QC, Québec, Canada Syneos Health Full timeDescription Senior Project Specialist This role is hybrid - requiring 50% time in the Burlington, Ontario office. 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....
-
Sr Project Manager
Found in: Jobillico Premium CA C2 - 7 days ago
Quebec City, Canada Syneos Health Full timeDescription Senior Project Manager 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. Our Clinical Development model brings the customer and the patient to the...
-
Specialist/Project Manager, quality assurance
2 weeks ago
Quebec, Canada Fopconsultants Full timeBrief description of the position : In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for quality assurance consultants to carry out various mandates. The main missions would be to review and approve the quality documents (SOP, protocols, etc.), collaborate on client’s complaints, write nonconformity,...
-
Quebec, Canada Fopconsultants Full timeBrief description of the position : In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for quality assurance consultants to carry out various mandates. The main missions would be to review and approve the quality documents (SOP, protocols, etc.), collaborate on client’s complaints, write nonconformity,...
-
Quebec, Canada Fopconsultants Full timeBrief description of the position : In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for quality assurance consultants to carry out various mandates. The main missions would be to review and approve the quality documents (SOP, protocols, etc.), collaborate on client’s complaints, write nonconformity,...
-
Sr Project Manager
Found in: Adzuna CA C2 - 5 days ago
Quebec City, QC, Québec, Canada Syneos Health Full timeDescription Senior Project Manager 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. Our Clinical Development model brings the customer and the patient to the...
-
Maintenance Project Manager
6 days ago
Quebec City, Canada amaris Full timeJob description We are looking for dynamic consultants to grow our Life Sciences team in Montreal. Your experience, knowledge, and commitment will help us to face our client's challenges. You will be supporting different projects through your expertise as a Maintenance Project Manager. **Your main responsibilities**: Management of technical improvement...
-
Clinical Operations Manager-1
2 days ago
Quebec City, Canada Parexel Full time**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 on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations,...
-
Quality Assurance Specialist
4 days ago
Quebec City, Canada Bossard Canada Full timeWe are looking for a detail-oriented quality assurance specialist to be in charge of all quality assurance activities. The quality assurance specialist's responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions. To be...
-
Project Management
2 weeks ago
Quebec, Canada Intact Financial Corporation Full timeWith purpose-driven innovation and our inspired work environment, you can make a difference delivering positive solutions through collaboration and planning. Check out the #IntactCareers Q&A series featuring our colleagues from coast-to-coast and learn about how they're growing with us. Category Project Management Job Id: R138778 ...
-
Project Management
1 week ago
Quebec, Canada Intact Financial Corporation Full timeWith purpose-driven innovation and our inspired work environment, you can make a difference delivering positive solutions through collaboration and planning. Check out the #IntactCareers Q&A series featuring our colleagues from coast-to-coast and learn about how they're growing with us. Category Project Management Job Id: R138778 ...
