Regulatory Affairs Specialist

2 weeks ago

Mississauga, Canada BD Full time

**Job Description Summary**: This position will provide regulatory support to BD operations for market entry and maintenance of BD products including medical devices, drugs and natural health products.

**Be part of something bigger**

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

This position will be Hybrid at our Mississauga, ON location.

**DUTIES & RESPONSIBILITIES**:

- Provide guidance and interpretation of regulatory requirements to the business, development teams, and worldwide regulatory partners
- Classification and preparation of Health Canada regulatory submissions for registration of medical devices including IVDD, drugs and natural health products
- Life cycle maintenance of Product Licenses including but not limited to assessment of changes to determine Health Canada reporting pathway
- Assist in the management of regulatory compliance activities including coordination of product recalls, support during audits and inspections
- Assist in the management of regulatory activities involving compliance to government regulations and maintenance of product licenses, establishment licenses and quality system certificates
- Proactively suggest improvements to submission management based on emerging submissions intelligence
- Represent BD on external committees (e.g. Medtech Canada sub-committees) as required
- Assist with other BD business needs

**QUALIFICATIONS**

**ABILITIES**:

- Excellent verbal and written communication skills
- Flexible and adaptable to fulfill business priorities
- Excellent attention to details
- Excellent collaboration and team work skills
- Strong project / submissions management skills (Ability to prioritize and manage multiple deadlines)
- Strong organization and time management skills to handle multiple activities
- Results driven
- can be counted on to achieve goals successfully
- Continuous Versatile Learning - has the functional and technical knowledge and skills to do the job at a high level of accomplishment

**KNOWLEDGE & SKILLS**:

- Minimum Bachelor of Science degree in life sciences; Advanced Science Degree preferred
- Post-graduate certificate in Regulatory Affairs preferred
- Minimum 2 - 5 years regulatory affairs experience in the medical device industry, pharmaceutical experience is an asset
- Working knowledge of Canadian regulations for medical devices and drugs
- For many roles _at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law._

**Why join us?**

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
- Great Place to Work® has certified our workplace culture based on your feedback in the Trust Index® survey, and we've just published the news about us on their social media channels. You can check these out here. And if you think your friends and networks would be interested in knowing more about your workplace, sharing these posts is a great way to give them some insight_

PDN

**Primary Work Location**: CAN Mississauga - Derry Road West

**Additional Locations**:
**Work Shift**:

  • Cosmetics Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Canada CbayExpress Corporation Full time

    **Job Position: Cosmetics Regulatory Affairs Specialist** **Location**: Onsite - Mississauga, Ontario **Working Days**: Monday to Friday **Key Responsibilities**: - Prepare and submit regulatory documentation for cosmetic product approvals and registrations. - Ensure compliance with all relevant regulations, guidelines, and standards related to...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Canada KIA CANADA INC Full time

    **Regulatory Affairs Specialist** The overall purpose of this position is to be a Canadian Regulatory Expert (Federal and Provincial) to liaise between government bodies and the Company’s factories to ensure compliance with all legislations and regulations related to all Company products. This position reports to the National Manager, Government...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Canada BD Full time

    **Job Description Summary**: We are** the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Canada ct bakery Full time

    _We are seeking a dedicated Regulatory Affairs Specialist - _**Food Industry**_ _to join our team. The Regulatory Affairs Manager will play a crucial role in guiding regulation strategies. This position requires strong regulatory knowledge, strategic thinking, and the ability to collaborate effectively across departments and with regulatory...

  • Quality Assurance

    2 weeks ago

    Mississauga, Canada Hansamed Ltd. Full time

    **Quality Assurance & Regulatory Affairs Specialist position** HANSAmed is a specialty Cell-Tissue-Organs, Medical Device, and pharmaceutical distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed...

  • Regulatory Affairs Specialist

    6 hours ago

    Mississauga, Ontario, Canada Reckitt Benckiser LLC Full time

    Job OverviewWe are seeking a highly motivated Regulatory Affairs Specialist to join our team at Reckitt Benckiser LLC. In this role, you will have the opportunity to ensure the highest quality of our new products and contribute to the success of our dynamic and fast-paced environment.

  • Regulatory Affairs Specialist

    4 days ago

    Mississauga, Ontario, Canada Reckitt Benckiser LLC Full time

    About ReckittReckitt Benckiser LLC is a global leader in consumer goods, dedicated to protecting, healing and nurturing in the relentless pursuit of a cleaner, healthier world. Our purpose defines why we exist: to create a better life for everyone, today and for generations to come.The Role:We are seeking a highly skilled Regulatory Affairs Senior Associate...

  • Regulatory Affairs Specialist

    1 day ago

    Mississauga, Ontario, Canada Teachers Life Insurance Full time

    Job SummaryWe are seeking a highly experienced Director, Compliance to lead our regulatory affairs efforts. As a key member of our leadership team, you will be responsible for developing and implementing compliance strategies that align with Teachers Life's business objectives.Key ResponsibilitiesDevelop and implement compliance policies and procedures to...

  • Director of Regulatory Affairs

    6 days ago

    Mississauga, Ontario, Canada Natco Pharma (Canada) Inc. Full time

    We are seeking an experienced Director of Regulatory Affairs to join our team at Natco Pharma (Canada) Inc. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products comply with all relevant regulatory requirements.About Our CompanyNatco Pharma (Canada) Inc. is a leading pharmaceutical company focused on research...

  • Regulatory Affairs

    4 weeks ago

    Mississauga, Ontario, Canada Reckitt Benckiser LLC Full time

    Regulatory Affairs & Safety AssociateHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Canada ct bakery Full time

    The primary focus of the role is to ensure the accuracy of the regulatory information in our databases for ingredients, allergens, formulas and labels; - Issuance of label information documents that comply with the regulations; and regulatory compliance of final product labels including product naming, ingredients, nutrition facts, claims, third party...

  • Regulatory Affairs Specialist Associate

    1 week ago

    Mississauga, Canada Zimmer Biomet Full time

    **Requisition Number**: AMER27090 **Employment Type**: Full-time **Location**: Mississauga **Job Summary**: Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around...

  • Regulatory Affairs Intern

    2 weeks ago

    Mississauga, 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**: - **...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Canada Profound Medical Full time

    Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic,...

  • Regulatory Affairs Manager

    3 weeks ago

    Mississauga, 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...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Canada Profound Medical Full time

    Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic,...

  • Regulatory Affairs Strategist

    3 days ago

    Mississauga, Ontario, Canada GlaxoSmithKline Full time

    Job Description">The Regulatory Affairs Manager will develop regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area. They are accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Canada CT Bakery Full time

    Job Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...

  • Regulatory Affairs Mgr

    3 weeks ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Jan 15 2025 If you are an experienced Regulatory Affairs professional with a commitment to excellence and creativity, we want to hear from you! As a **Regulatory Affairs Manager**at **GSK**, you will manage a portfolio of products and collaborate with a diverse range of global and local...

  • Regulatory Affairs Mgr

    3 weeks ago

    Mississauga, Ontario, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: Mar 11 2025If you are an experienced Regulatory Affairs professional with a commitment to excellence and creativity, we want to hear from you As a Regulatory Affairs Manager at GSK, you will manage a portfolio of products and collaborate with a diverse range of global and local cross-functional teams. You...