Jobs
>
Mississauga

    Senior Regulatory Affairs Associate - Mississauga, Canada - Boston Scientific

    Boston Scientific
    Boston Scientific Mississauga, Canada

    2 weeks ago

    Default job background
    Description
    Additional Locations:
    Canada-ON-Mississauga


    About the Opportunity

    At 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 propel your career forward. Our supportive environment ensures you thrive, no matter your career aspirations.

    Job Details

    The role of Regulatory Affairs Senior Associate is to assist the Regulatory Affairs Manager in securing swift approvals for our product lines. This includes planning and overseeing product registrations, as well as engaging with regulatory authorities to expedite approvals and address inquiries.


    Your Responsibilities:
    • Submit medical device license applications and regulatory dossiers to Health Canada, FDA, and EU Notified Body
    • Develop regulatory strategies for new product launches
    • Assist in assessing new products and changes in product designs
    • Review design history files and provide regulatory guidance to R&D
    • Review labeling and promotional materials
    • Create SOPs
    • Build and maintain positive relationships with internal and external stakeholders
    • Stay updated on regulatory developments
    • Ensure compliance with all Corporate, Quality, and Health and Safety protocols
    • Perform other duties as necessary

    Required Qualifications:
    -Minimum of 4 years of relevant experience in the medical device sector
    • Familiarity with Canadian, US, and EU medical device regulations
    • Understanding of medical device development processes and design control requirements

    Preferred Qualifications:
    • Master's degree in Life Science or related field
    • Post Graduate Certificate in Regulatory Affairs
    • Adaptability, positive attitude, and strong interpersonal skills
    • Strong attention to detail and accuracy
    • Proficient in drafting submission materials
    • Excellent communication and organizational abilities
    • Ability to collaborate effectively with diverse teams
    • Proven track record of managing multiple priorities in a fast-paced setting

    About Boston Scientific

    With over 40 years of leadership in medical science, we are dedicated to addressing significant healthcare challenges, driven by a profound respect for human life. Our mission to enhance lives through innovative medical solutions underscores our commitment to patients, customers, employees, and communities. Our global responsibility influences every aspect of our work, shaping us not just as a business entity but as a corporate citizen.

    If you're a natural-born troubleshooter with the creativity, perseverance, and passion to make a genuine impact on a global scale, Boston Scientific (NYSE: BSX) invites you to explore career opportunities with us. We anticipate the opportunity to engage with you and welcome you to our team.

  • 837 GlaxoSmithKline Inc.

    Medical Affairs Associate

    2 weeks ago

    837 GlaxoSmithKline Inc. Mississauga, Canada Full time

    Medical Affairs Associate, Vaccines - Contract · Key responsibilities include and are not limited to: · Being an active member of the Vaccines Medical Affairs team making meaningful contributions towards the execution and implementation of local medical plans and overall medic ...

  • AstraZeneca

    Regulatory Affairs Associate

    3 weeks ago

    AstraZeneca Mississauga, Canada

    Regulatory Affairs Associate · Hybrid Work- on average 3 days/week from office · Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office · At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ...

  • AstraZeneca

    Associate Regulatory Affairs Director

    3 weeks ago

    AstraZeneca Mississauga, Canada 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 ind ...

  • Boston Scientific

    Regulatory Affairs Senior Associate

    2 weeks ago

    Boston Scientific Mississauga, ON, Canada

    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 he ...

  • Gilead Sciences, Inc.

    Local Regulatory Affairs Associate

    3 weeks ago

    Gilead Sciences, Inc. Mississauga, ON, Canada Full time

    CMC Regulatory Affairs Associate II page is loaded CMC Regulatory Affairs Associate II · Apply locations Canada - Ontario - Mississauga time type Full time posted on Posted Yesterday job requisition id R At Gilead Sciences Canada Inc. we take pride in being recognized as one of ...

  • AstraZeneca

    Associate Regulatory Affairs Director, Vaccines

    3 weeks ago

    AstraZeneca Mississauga, Canada 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 ...

  • Boston Scientific Gruppe

    Regulatory Affairs Senior Associate

    3 weeks ago

    Boston Scientific Gruppe Mississauga, ON, Canada

    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 empl ...

  • Amgen SA

    Associate, Legal and Regulatory Affairs

    1 week ago

    Amgen SA Mississauga, ON, Canada

    It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Associate, Marketing - Oncology and Inflammation Business Unit · Reports to: Oncology, Business Unit Director · Level: 3 or 4 · Work with the cross-functi ...

  • Gilead Sciences Canada, Inc.

    CMC Regulatory Affairs Associate II

    17 hours ago

    Gilead Sciences Canada, Inc. Mississauga, Canada 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 car ...

  • 837 GlaxoSmithKline Inc.

    Medical Affairs Associate, Specialty Care

    4 weeks ago

    837 GlaxoSmithKline Inc. Mississauga, Canada Full time

    In this position you may participate in: · Be an active member of a medical affairs team (Specialty Care, Rheumatology) and assist in the development and execution of local medical strategies. · Support cross-functional initiatives across a range of disciplines including medical ...

  • Gilead Sciences, Inc.

    CMC Regulatory Affairs Associate II

    3 weeks ago

    Gilead Sciences, Inc. Mississauga, Canada

    CMC Regulatory Affairs Associate II page is loaded · CMC Regulatory Affairs Associate II · Apply locations Canada - Ontario - Mississauga time type Full time posted on Posted Yesterday job requisition id R At Gilead Sciences Canada Inc. we take pride in being recognized as one o ...

  • Bayer

    Regulatory Affairs Associate

    3 weeks ago

    Bayer Mississauga, Canada

    **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 per ...

  • Natco Pharma (Canada) Inc.

    Associate, Regulatory Affairs

    3 weeks ago

    Natco Pharma (Canada) Inc. Mississauga, Canada

    **Associate, Regulatory Affairs** · Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated generic pharmaceutical company focused on research & development, and the manufacturing of active pharmaceutical ingredients (API) and finish ...

  • Amgen

    Regulatory Affairs Associate

    2 weeks ago

    Amgen Mississauga, Canada

    Career Category · Regulatory · **Job 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 goa ...

  • Seaford Pharmaceuticals Inc.

    Regulatory Affairs Associate

    2 weeks ago

    Seaford Pharmaceuticals Inc. Mississauga, Canada

    Under the direction of the department manager, the Regulatory Associate is responsible to carry out regulatory functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford's operations. · This position is responsible to particip ...

  • Natco Pharma (Canada) Inc.

    Associate, Regulatory Affairs

    2 weeks ago

    Natco Pharma (Canada) Inc. Mississauga, Canada

    **About Natco**: · Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world's ...

  • Amgen

    Regulatory Affairs Associate

    2 weeks ago

    Amgen Mississauga, Canada

    **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 ...

  • Mint Pharmaceuticals Inc.

    Regulatory Affairs Associate

    2 weeks ago

    Mint Pharmaceuticals Inc. Mississauga, Canada

    Job description · Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the hig ...

  • GSK

    Medical Affairs Associate

    2 weeks ago

    GSK Mississauga, Canada

    **Site Name**: Canada - Ontario - Mississauga · **Posted Date**: Jun 3 2024 · **Medical Affairs Associate, Vaccines - Contract** · **Key responsibilities include and are not limited to**: · - Being an active member of the Vaccines Medical Affairs team making meaningful contributi ...

  • Dr. Reddy's Laboratories, Inc.

    Associate Regulatory Affairs

    4 weeks ago

    Dr. Reddy's Laboratories, Inc. Mississauga, Canada

    **Description** · **At 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 ...