Regulatory Affairs Senior Associate

7 days ago


Mississauga, Ontario, Canada Boston Scientific Gruppe Full time
Press Tab to Move to Skip to Content Link
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.

With access to the latest tools, information and training, we'll help you in advancing your skills and career. Please note this is a 1-year contract opportunity.

The Regulatory Affairs Senior Associate supports the Manager, Regulatory Affairs in ensuring rapid and timely approvals for respective product lines.

This involves planning for all product registration and managing all product registrations' preparation and documentation.

Furthermore, they will interact with regulatory agency personnel to expedite approval of pending registration as well as answer any questions on product documentation.

Plan, organize, assemble and file medical device license applications and regulatory dossiers to Health Canada, FDA and EU Notified Body
Develop and communicate regulatory affairs strategy for new product introduction and other projects
Assist with regulatory assessment of new products and changes made to the product
Review of design history file documents and advise R&D team on regulatory requirements
Stay abreast of regulatory changes
Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures
4+ years of relevant experience in the medical device industry
Sound knowledge of Canadian, US, and EU regulations and guidelines for medical devices
Sound knowledge of medical device development process and design control requirements, including risk management
Master's degree in Life Science or related field
Post Graduate Certificate in Regulatory Affairs
Ability to adapt and be flexible, positive attitude and excellent interpersonal skills
Excellent writing skills, as demonstrated through submission writing experience

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.

Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (

NYSE:
BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

Regulatory Affairs, Medical Device, Compliance, R&D, Law, Legal, Healthcare, Research
SAP as service provider
"careerSiteCompanyId" is used to send the request to the correct data center
"

  • Mississauga, Ontario, Canada Boston Scientific Full time

    Additional Locations:Canada-ON-MississaugaAbout the OpportunityAt Boston Scientific, we provide you with the chance to unleash your full potential by collaborating with a diverse team of top-notch employees, addressing crucial challenges in the healthcare industry. You'll have access to cutting-edge tools, resources, and training to enhance your skills and...


  • Mississauga, Ontario, Canada Amgen Full time

    Career CategoryRegulatoryJob Description:HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our...


  • Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Additional Locations: Canada-ON-Mississauga Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all...


  • Mississauga, Ontario, Canada Bayer Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Mississauga, Ontario, Canada Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...


  • Mississauga, Ontario, Canada Gilead Sciences Canada, Inc. Full time

    Description Being Here Matters At Gilead, Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases. We are driven to...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functional and global? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with...


  • Mississauga, Ontario, Canada GSK Full time

    Site Name: Mississauga Milverton DrivePosted Date: Jun Key Accountabilities/Responsibilities**: Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area. Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions...


  • Mississauga, Ontario, Canada Dr. Reddy's Laboratories, Inc. Full time

    DescriptionAt Dr. Reddy's "Good Health Can't Wait"By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Ontario, Canada Optimum Staffing Solutions Inc. Full time

    Our client is a vibrant and expanding company seeking a dedicated professional in Regulatory Affairs to bolster their progression. The Regulatory Affairs (RA) Manager will offer regulatory expertise and assistance for approval and maintenance activities aligning with Federal regulatory prerequisites for Canada and the United States.This role represents a...


  • Mississauga, Ontario, Canada Bayer Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca, we foster a collaborative culture that promotes knowledge-sharing, encourages ambitious thinking, and drives innovation - providing our employees with the opportunity to collaborate across teams, functions, and locations worldwide.Our ways of working prioritize individualized flexibility, allowing employees to balance personal and...


  • Mississauga, Ontario, Canada AtkinsRéalis Full time

    Director - New Build Regulatory AffairsAtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are proud to be the steward of Canadian CANDU nuclear technology.Location - Mississauga, ONYour role...


  • Mississauga, Ontario, Canada GE Healthcare Full time

    Job Description Summary:The Regulatory Affairs Intern will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support.Key responsibilities/essential functions include:- Create...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Join AstraZeneca for a rewarding Regulatory Affairs Project Director (RAPD) role!AstraZeneca values a collaborative culture that encourages knowledge-sharing and innovative thinking among its employees. At our head office and BlueSky Hub in downtown Toronto, designed for collaboration, enjoy working face-to-face with your team 3 days a week. You'll be part...


  • Mississauga, Ontario, Canada BAXTER Full time

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...


  • Mississauga, Ontario, Canada Alectra Utilities Full time

    Job Posting Number: Position:Specialist, Regulatory AffairsLocation:Mississauga (Derry)(Hybrid: Remote/In-office)Reports to:Manager, Rate Applications & ForecastingBusiness Unit:Finance & RegulatoryDivision:Regulatory AffairsHours per Week:35Rate of Pay:Number of Openings:1Union:NoOpen:November 23, 2023Close:December 6, 2023 Alectra is committed to putting...


  • Mississauga, Ontario, Canada Trexo Robotics Full time

    Trexo Robotics (Y Combinator Company) is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. We are constantly working towards building mobility solutions for all. We are a fast-growing...