Regulatory Affairs Specialist
2 days ago
Head Office: Edmonton, AB
Working Arrangement: This position offers flexibility with options for hybrid (combination of in-office and remote) or fully remote work.
Position: Permanent, Full-Time
Reporting to: Director, Commercial Operations
Salary Range: $80,000 - $120,000
Ready to Make a Difference? Step into a Role That Shapes the Future of Medical Innovation – Apply Now and Let Your Expertise Drive Global Impact
We are seeking an experienced Regulatory Affairs Specialist to provide strategic guidance and support for regulatory compliance and submissions related to medical devices. This role focuses on both software and hardware-based devices, ensuring compliance with Health Canada and FDA regulations. The successful candidate will develop regulatory strategies, lead submissions, and mentor junior staff while collaborating with cross-functional teams to support clients' regulatory needs.
Key Responsibilities
- Serve as the primary regulatory point of contact for clients, guiding them through regulatory pathways.
- Prepare and manage regulatory submissions for medical devices (e.g., SaMD and hardware).
- Ensure compliance with Health Canada and FDA regulations, including ISO 13485 standards.
- Conduct regulatory assessments, gap analyses, and document reviews.
- Mentor junior staff and foster a collaborative team environment.
- Bachelor’s degree in a relevant field (Master’s preferred).
- Regulatory Affairs Certification (RAC) is an asset.
- Minimum of 5 years of experience in regulatory affairs for medical devices, including software and hardware products.
- Proven expertise with Health Canada and FDA submissions (e.g., MDL, ITA, 510(k), PMA).
- Strong knowledge of medical device regulations, design controls, and post-market surveillance.
- Excellent communication, problem-solving, and project management skills.
- And, must have the authority to work in Canada.
- Extended health benefits
- Professional development.
- Transit allowance
TSSHP LI-TS1
Job Posting ID: (#16576103)
Thank you for your interest in this job posting.
We look forward to hearing from you.
TalentSphere Staffing Solutions
talentsphere.ca
Canada
Toronto: 416.900.3435 Calgary: 403.910.9222 Edmonton: 587.333.7929 Halifax: 902.800.7808 Kelowna: 250.448.8880 Montreal: 438.448.4300 Mississauga: 905.919.3688 Ottawa: 613.783.1441 Vancouver: 778.807.9777 Victoria: 250.294.8095 Winnipeg: 204.285.3905
United States
USA Toll-Free: 1855.900.3435 Dallas 469.498.2002 Los Angeles 213.290.4030
-
Manager, Operations
4 days ago
Edmonton, Canada Flair Airlines Ltd. Full time**Are you ready to take your career to new heights?** **Job Title**: Manager, Operations & Regulatory Affairs **Department**: Flight Operations **Location**:Vancouver, BC, Calgary, AB, Edmonton, AB, Toronto, ON **Work Arrangement**:This role is primarily based in the office environment. **Position Overview**: The Manager, Operations & Regulatory...
-
Regulatory Communications Specialist
7 days ago
Edmonton, Alberta, Canada Alberta College of Dental Hygienists Full timeThe Alberta College of Dental Hygienists is seeking a highly skilled Regulatory Communications Specialist to join our team. This role is responsible for executing organizational communication strategies, drafting and delivering regulatory messages to various stakeholders, assisting with college events, and developing and reviewing documents, educational...
-
Communications Specialist, Academic Affairs
4 days ago
Edmonton, Canada MacEwan University Full timeCOMMUNICATIONS SPECIALIST, ACADEMIC AFFAIRS **OFFICE OF THE PROVOST & VICE-PRESIDENT, ACADEMIC** **Competition No.** 25.01.23 **CATEGORY** **SALARY** **CLOSING DATE** - Full-Time Replacement Term (35 hours per week) - MSA Band F (Steps 1-8): $33.605 - $48.887 per hour. $61,162 - $88,975 per annum (Based on 35 hours per week). - January 27, 2025 **About...
-
Edmonton, Alberta, Canada Starlight Energy Full timeCompany OverviewStarlight Energy is a leading renewable energy developer specializing in solar and battery energy storage systems. We strive to advance clean energy solutions while collaborating with communities, stakeholders, and regulatory bodies.
-
Edmonton, Alberta, Canada Starlight Energy Full timeAbout Starlight Energy:">We are committed to advancing clean energy solutions while working collaboratively with communities, stakeholders, and regulatory bodies. As we expand our presence in the renewable energy sector, we seek a talented and motivated Regulatory and Public Consultation Manager to drive our development forward.
-
Regulatory Communications Specialist
6 days ago
Edmonton, Alberta, Canada Alberta College of Dental Hygienists Full timeAbout the RoleWe are seeking a skilled Communications Coordinator to join our team.The successful candidate will be responsible for executing organizational communication strategies, drafting and delivering regulatory messages to various stakeholders, and assisting with college events.This role requires strong writing and editing skills, attention to detail,...
-
edmonton, Canada Starlight Energy Full timeTHE ROLEStarlight is a leader in renewable energy development, specializing in solar and battery energy storage systems (BESS). We are committed to advancing clean energy solutions while working collaboratively with communities, stakeholders, and regulatory bodies. As we expand our Alberta portfolio, we seek a talented and motivated Regulatory and Public...
-
Senior Risk Management Specialist
4 days ago
Edmonton, Alberta, Canada Credit Union Deposit Guarantee Corporation (Alberta) Full timeAbout Us">The Credit Union Deposit Guarantee Corporation is a not-for-profit public agency of the Government of Alberta, responsible for guaranteeing deposits and providing risk-based regulatory oversight to ensure a safe and sound credit union system in Alberta.">Our Primary Roles">">We provide a 100% guarantee of deposits held with Alberta credit...
-
Environmental Health and Safety Specialist
5 days ago
Edmonton, Canada Ventura Foods Full timeEnvironmental Health & Safety (EHS) Specialist - Edmonton **Position Overview**: Reporting to the Director of Quality and Compliance, the EHS Specialist is responsible for the overall support, strategy, development and deployment of the Health & Safety and Environmental Programs for Ventura Foods Edmonton facility. **Coverage in case of Absence**: In the...
-
Environmental Specialist
16 hours ago
Edmonton, Canada HumanEdge Global Full timeOpportunity Profile Environmental Specialist / Biologist CharettePellPoscente (CPP) Environmental THE ORGANIZATION CPP Environmental (www.cppenv.ca) employs a multidisciplinary team of experts specializing in land, water, and natural resource management. Combined, the company possesses the capacity to address a variety of environmental related issues...
-
Credit Union Deposit Guarantee Corporation
5 days ago
edmonton, Canada Credit Union Deposit Guarantee Corporation (Alberta) Full timeThe Credit Union Deposit Guarantee Corporation is a not-for-profit public agency of the Government of Alberta that guarantees deposits and provides risk-based regulatory oversight to enable a safe and sound credit union system in Alberta. Providing a 100% guarantee of deposits held with Alberta credit unions Regulating credit unions and enforcing the...
-
Edmonton, Canada Scotiabank Full timeRequisition ID: 161351 Join the Global Community of Scotiabankers to help customers become better off. **#LI-Remote, #LI-Hybrid** **Purpose of Job** The Assistant, Investment Specialist will be responsible for working with an Investment Specialist(s) in support of their development of new wealth management business relationships in target markets. In...
-
Data Management Specialist
1 week ago
Edmonton, Alberta, Canada Teckhorizon Inc Full timeAbout UsAt Teckhorizon Inc, we are committed to maintaining the highest standards of data integrity and compliance.Job SummaryWe are seeking a highly organized and detail-oriented Data Management Specialist to join our team. In this role, you will be responsible for managing and maintaining accurate and up-to-date records, ensuring compliance with regulatory...
-
Compliance Specialist
4 days ago
Edmonton, Canada The Brick Full timeIs this job for you?: We are growing and looking to add a **Compliance Specialist** to our team Trans Global Insurance Group (TGI) includes a Property and Casualty coverage company and a Life Insurance Company. TGI was founded nearly 25 years ago with the aim of providing Canadians with simple and straightforward coverage that provides security and peace...
-
Reclamation Specialist
10 hours ago
Edmonton, Canada Nichols Full timeReclamation Specialist – Edmonton or Calgary, Alberta Nichols Environmental (Canada) Ltd. (Nichols) is a full-service geo-environmental consulting and remediation firm that provides environmental and engineering solutions to a wide range of industrial, government and public sector clients. Nichols continues to expand our operations throughout western...
-
Oil & Gas Specialist
5 days ago
Edmonton, Canada WestMET Group Canada Full time**Oil & Gas Specialist** **Company Description** At WestMET, we are creating value by developing and growing a portfolio of complementary businesses that support a sustainable economic future in the Minerals, Energy and Technology sectors. Our current business segments include: 1. _WestMET Ag_ - This agriproducts division is focused on the production and...
-
Inventory Specialist
3 days ago
Edmonton, Canada Token Naturals Full time**About Token Naturals** Token Naturals is an Edmonton-based independent cannabis company, creating products for companies and consumers. We make our own branded cannabis products for the recreational market and we serve industry clients with white label products and contract manufacturing. Our company is powered by people. We take a values-forward...
-
Lead Financial Reporting Specialist
2 days ago
Edmonton, Alberta, Canada Sadovnick Morgan LLP Full timeAt Sadovnick Morgan LLP, we are a chartered professional accountant firm that provides comprehensive services to support private enterprises, family businesses, professionals, and individuals.We aim to empower our clients navigate complex regulatory requirements so they can focus on growing their businesses. Our team of experts offers tailored accounting...
-
Environmental Specialist
1 day ago
Edmonton, Canada HumanEdge Global Full timeOpportunity Profile Environmental Specialist / Biologist CharettePellPoscente (CPP) EnvironmentalTHE ORGANIZATIONCPP Environmental (www.cppenv.ca) employs a multidisciplinary team of experts specializing in land, water, and natural resource management. Combined, the company possesses the capacity to address a variety of environmental related issues relevant...
-
Railway Bridge Technical Specialist Vacancy
2 days ago
Edmonton, Alberta, Canada Disability Solutions Full timeAbout the RoleCN is seeking a talented Railways Bridge Technical Specialist to join our team. As a key member, you will be responsible for creating designs and leading design projects assigned to consultants for bridges across CN's network. You will work in accordance with internal policies and American Railway Engineering and Maintenance of Way Association...