Regulatory Affairs Specialist
6 months ago
**See if you are our next**:
**BILLINGUAL REGULATORY AFFAIRS SPECIALIST (Operating Room Experience Required)**
Working at Vision Group's head office is working for the North American leader in vision correction. It means being able to concretely contribute to the development of the company and support more than 12 brands and more than 70 clinics across Canada and the United States. It's about having the wind in your sails and getting things done as a team in a relaxed environment. And all of this, while benefiting from a teleworking formula adapted to each employee.
Reporting to the National Accreditation Advisor, the Accreditation Assistant will function as administrative support to the National Accreditation Advisor and ensure that the requirements for facility accreditation are met and maintained.
Join our team, where our Great Place to Work® certification represents our commitment to creating a supportive and inclusive culture for every member of our organization.
**Your tasks at a glance**
- You foster a culture of excellence and compliance.
- You ensure accredited facilities are accreditation ready via virtual and onsite clinic audits.
- You assess compliance to regulatory standards and identify areas to be addressed.
- You assist the Accreditation team during regulatory inspection which may include face to face communication with regulators.
- You act as a liaison between Vision Group facilities and the OR Affairs team.
- You work cross-functionally with various departments related to Accreditation projects.
- You support the creation and maintenance of online references such as SharePoint spaces, internal Vision Group standard operating procedure manuals, and clinic Accreditation policy & procedure manuals.
- You lead the clinics’ annual statistics reporting, MD privileging & annual renewals, and facility fee approvals & invoicing.
- You assist with preparing & submitting communication, forms, and accreditation follow up reports to various regulatory bodies.
- You travel within Canada (possibly the US) when required, sometimes on short notice (mostly in GMA & GQA).
- You manage accreditation timelines and all record keeping in Microsoft TEAMS with a high degree of organization and attention to detail.
- You assist and/or lead training and coaching sessions with the Centre Directors to facilitate the understanding of accreditation standards.
- You support the development of mEYEstro to meet accreditation requirements, surgical assistant efficiency and end-user needs.
- You support clinic management with various accreditation and OR affairs initiatives including accreditation prep, staff validations, & audits.
- You prepare MD communications for the department.
- You support the OR Affairs department in future projects related to accreditations. Other areas of support may include but are not limited to a focus on IOL Coordinators, Surgical Assistants & Nurses (all procedure types), Medical Device Reprocessing, and diagnostic equipment.
**A clear view of your assets**
- You have at least 3 years of experience working in a clinical/surgical setting.
- Your nursing background is an asset.
- You have experience in the development, implementation, and evaluation of standard operating procedures, as well as quality improvement projects in a medical setting.
- You have excellent communication skills, you speak English _et français également pour supporter nos cliniques canadiennes._
- You have exceptional organizational skills.
- You have knowledge of provincial accreditation standards and have experience in managing healthcare accreditation/review processes is an asset.
- You are self-motivated with an ability to work remotely under mínimal supervision.
- You are detail oriented and a keen eye for efficiency.
- You communicate with MD’s and regulatory bodies with the utmost accuracy.
- You are proficient with Microsoft Office (TEAMS, Sharepoint, Excel, Word, Outlook, PowerPoint, etc).
- You are agile and can work in a fast-paced environment with tight deadlines.
- You have strong interpersonal skills and demonstrate a collaborative approach.
- You are recognized for your teamwork and peer support by always being available when colleagues need support.
**From our point of view
-
Regulatory Affairs Specialist
5 months ago
Montréal, Canada SeeSpine Full time**About us** We are professional, agile, and innovative. Our work environment includes: - Modern office setting - Food provided - Modern office setting - Growth opportunities - Wellness programs - Work-from-home days Job Summary: We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. As a Regulatory Affairs...
-
Regulatory Affairs Specialist
5 months ago
Montréal, Canada Novartis Full time**Summary**: Location: Montreal, #LI-Hybrid About the role: The role reports to Regulatory Affairs Franchise Lead and will work with different team members. Temporary - 9 to 12 months **About the Role**: **Key Responsibilities**: - Assists in the preparation of and/or review of various regulatory submissions for new or marketed products and ensures optimal...
-
Regulatory Affairs, Associate
1 month ago
Montréal, QC, Canada Euro-Pharm Full timeJob Summary Working within Regulatory Affairs, reporting to Head, Regulatory Affairs, Associate, Quality & Regulatory Affairs is responsible for performing the required tasks related to Regulatory Affairs. Principal Responsibilities **Regulatory Affairs**: Coordinate with the Export department the regulatory and quality documents required for product...
-
Regulatory Affairs Associate
5 months ago
Montréal, Canada Allphase Clinical Research Inc. Full timeCalian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to-day regulatory activities? If so, we would love to hear from...
-
Regulatory Affairs Specialist
6 months ago
Montréal, Canada vitaltracer Full timeWork Term: Permanent - Work Language: English - Hours: 38 to 44 hours per week - Education: Master's degree - Experience: 5 years or more - Bioengineering and biomedical engineering - Mechanical engineering **Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Develop quality management and quality...
-
Associate, Regulatory Affairs
6 months ago
Montréal, Canada Endo International Full timeJob Description Summary At Paladin, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you! This position requires a...
-
Regulatory Affairs Specialist
6 months ago
Montréal, Canada vitaltracer Full timeWork Term: Permanent - Work Language: English - Hours: 42 to 44 hours per week - Education: Master's degree - Experience: 5 years or more **Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Conduct quality audits - Develop quality management and quality assurance standards - Conduct research to determine...
-
Regulatory Affairs Compliance Associate
6 months ago
Montréal, Canada Novartis Full time395204BR **Regulatory Affairs Compliance Associate**: Canada **About the role** Location: Montreal, #LI-Hybrid 13 month contract About the role: We are looking for an organized, collaborative and passionate regulatory affairs professional who is driven to help us deliver our innovative treatments to patients. As a compliance lead, you will report directly...
-
Fsp - Regulatory Affairs Associate
5 months ago
Montréal, Canada Calian Full timeCalian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to-day regulatory activities? If so, we would love to hear from YOU! Location -...
-
Associate, Regulatory Affairs
4 weeks ago
Montréal, QC, Canada Endo International Full timeJob Description Summary At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you! This position...
-
Regulatory Affairs Assistant
5 months ago
Montréal, Canada Innovaderm Research Full timeThe Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator’s Study Files (ISFs) for all studies at the clinical research unit. **RESPONSABILITIES** More specifically, the Regulatory Affairs Assistant must: - Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms)...
-
Regulatory Affairs and Political Analysis Advisor
2 months ago
Montréal, QC, Canada Ubisoft Full time**Company Description** Ubisoft’s 19,000 team members, working across more than 30 countries around the world, are bound by a common mission to enrich players’ lives with original and memorable gaming experiences. Their commitment and talent have brought to life many acclaimed franchises such as Assassin’s Creed, Far Cry, Watch Dogs, Just Dance,...
-
Quality Assurance Specialist
6 months ago
Montréal, Canada Endocision Technologies Inc. Full time**Title**:Regulatory Affairs & Quality Specialist **Reports to**: Director Regulatory Affairs and Quality Assurance **Profile**: The person will be responsible for the management and development of all quality and regulatory duties involving the following: ISO 13485, CE-Mark, Health Canada and FDA. The Regulatory Affairs & Quality Specialist will work...
-
Associé.e en Réglementation/regulatory
5 months ago
Montréal, Canada Zoetis Full timeLe rôle principal de l’associé(e) en réglementation - graphiste consiste à gérer la création et les révisions des maquettes pour les produits de santé animale. La personne titulaire du poste interagit directement avec les chefs de marque, des Affaires réglementaires, de l’Assurance qualité et de la Logistique. Ses fonctions administratives...
-
Manager, Government Affairs
5 months ago
Montréal, Canada Livent USA Corp Full time**About Arcadium Lithium**: We are change-makers, joining forces to drive progress. A world enabled by the critical mineral, Lithium - the elemental source powering modern life and our global transition to clean energy.For decades, we’ve grown alongside and collaborated with our people, our customers and communities. Pioneering, collaborating, and evolving...
-
Specialist Quality and Regulatory Affairs
2 days ago
Montréal, QC, Canada Knight Therapeutics Full timeMedical information and Patient Support Program (PSP) Specialist Knight Therapeutics Inc. is a pan-American (ex-US) specialty pharmaceutical company focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin...
-
Ssu & Regulatory Specialist Ii
3 months ago
Montréal, QC, Canada Syneos - Clinical and Corporate - Prod Full time**Description** **Site Start-Up & Regulatory Specialist II - Hybrid schedule (Montreal, 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...
-
Director, Public Affairs
6 months ago
Montréal, Canada adMare BioInnovations Full time**About adMare BioInnovations**: With a strong track record of globally competitive scientific discovery, Canadian life sciences is primed to lead the world. To make this a reality, adMare BioInnovations uses its scientific and commercial expertise, specialized R&D infrastructure, and seed capital to build strong life sciences companies, robust ecosystems,...
-
Regulatory and Start Up Specialist
6 months ago
Montréal, Canada Precision for Medicine Full time**Position** **Summary**: The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed...
-
Analyste, Affaires Réglementaires regulatory
3 weeks ago
Montréal, QC, Canada Keurig Dr Pepper Full time**Analyste, Affaires réglementaires** permenant, temps plein Montreal, hybride, 3 jours/semaine Lorsque vous travaillez chez KDP Canada, vous plongez au cœur des opérations internes de la troisième plus grande entreprise de boissons au Canada et vous visez un impact positif avec chaque boisson. Vous apprenez comment l'un des 100 meilleurs employeurs...