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Added 8 mins ago
H
Senior Internal Auditor
Héroux-Devtek
Longueuil, QC
- Full-time
Funding for additional technical, linguistic, and behavioral training relevant to the role and development.
Added 8 mins ago
RB
Senior Manager, AI Engineering (AML &Fraud)
Royal Bank of Canada
Vancouver, BC
- Full-time
The Senior Manager, AI Engineering (AML &Fraud) will lead a team delivering engineering solutions for fraud and AML capabilities across global groups. The role combines hands-on technical…
Added 8 mins ago
J
Senior Manager, Credit Risk
Jobber
Remote, Canada
- Full-time
- Remote
The Senior Manager, Credit Risk will lead and grow a team of Credit Risk Analysts, owning the day-to-day operations of the credit risk function while helping build it into something more…
Added 8 mins ago
SH
Provider Support Coordinator
Sailor Health
Remote, Canada
- $45,000 CAD / year
- Full-time
- Remote
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Added 9 mins ago
R
Senior BI Developer/ Data Analyst
Raise
Toronto, ON
- Full-time
We at Raise are hiring a Senior BI Developer/ Data Analyst for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising…
Added 53 mins ago
A
Hearing Aid Specialist or Audiologist
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Chilliwack, BC
- Full-time
…and providing personalized consultations. Reporting to the Senior Area Manager, you will lead sales of hearing aids and accessories while educating the community on the importance of…
Added 53 mins ago
IG
Product Manager
Insight Global
Vancouver, BC
- $65 to $72 CAD / hour
- Contract
Experience working with technical platforms and data-driven initiatives
Added 53 mins ago
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Senior Compensation Partner, Sales & Marketing
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Vancouver, BC · Greater Vancouver Metropolitan Area
- Full-time
The Senior Compensation Business Partner, Sales & Marketing is the trusted compensation advisor to Autodesk's Sales organization within the COO, covering both commissioned and…
Added 53 mins ago
A
Senior Compensation Partner, Sales & Marketing
Autodesk
Toronto, ON · Greater Toronto Area, Canada
- Full-time
The Senior Compensation Business Partner, Sales & Marketing is the trusted compensation advisor to Autodesk's Sales organization within the COO, covering both commissioned and…
Added 53 mins ago
TS
Sr Software Engineering Lead/ Architect
TalentSphere Staffing Solutions
Toronto, ON · North York, ON
- Full-time
Our client is seeking an experienced Senior Software Engineering Lead / Architect to join a product-focused engineering organization operating within a highly regulated environment.
Added 53 mins ago
T
Développeur logiciel senior - Plateforme centrale/ Senior Software Developer - Core Platform
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Montreal, QC
- Full-time
As a Senior Software Developer, you will play a leading role in building and improving the software that drives our vision to Create Moments that Move People. You will design and implement…
Added 53 mins ago
B
Senior Quality Manager
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Montreal, QC
- Full-time
Lead cross-functional quality activities through coaching, collaboration and technical expertise.
Added 1 hour ago
Director, Digital Experience
Sobeys Capital Incorporated or a Franchise/Affiliate / ou une franchise/société affiliée
Toronto, ON
…frictionless and high-performing experiences. The role will lead the UI/UX and digital product agenda, establishing customer journeys, experience principles, product priorities and a…
Added 1 hour ago
R
Senior Manager, AI Engineering (AML &Fraud)
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- Full-time
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Added 1 hour ago
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- Full-time
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Added 1 hour ago
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Senior Design Manager
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- Full-time
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Added 1 hour ago
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Senior Manager, Business Tax - Toronto
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Toronto, ON
- Full-time
Be empowered to lead and have impact with clients, our communities and in the office.
Added 2 hours ago
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Superintendent Technical Services, Red Chris Block Cave
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Spécialiste principal, Économie de la santé et étude des résultats thérapeutiques / Senior Specialist, Health Economics Outcomes Research
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- Full-time
Added 2 hours ago
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Manager of Financial Planning & Budgeting
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Lead Financial Excellence. Strengthen Community Outcomes.
Added 2 hours ago
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Product Manager II, Advanced Analytics, Tim Hortons, Canada
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Toronto, ON
- Full-time
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Added 2 hours ago
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Added 2 hours ago
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Civil Engineer
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- Full-time
…built environment. This isn’t just a job, it’s a chance to lead innovation, engineer impact, and build a legacy of…
Added 3 hours ago
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VP, Paid Media
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- Full-time
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Added 3 hours ago
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RQ11858 – Oracle Cloud Integration Specialist – Senior
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- Internship
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BlueRock Therapeutics

Senior Director, Technical Development Lead, Device

Toronto, ON, Canada

Full-time

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Job details

Job type: Full-time
Experience: 12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
Posting language: English
Posted: Jul 14, 2026

Original job description

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

What Are We Doing?

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.

We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy company harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of Position:

This role is responsible for providing strategic and technical leadership for the development and execution of potential delivery device systems supporting the company’s combination cell therapy portfolio. In addition, this role serves as the single point of accountability for program-level technical development, ensuring alignment from early development through clinical stages and commercialization readiness. The individual will bring deep expertise in medical device development and commercialization, integrated with biologics/cell therapy development, to enable successful delivery of complex combination products.

This leader will work cross‑functionally with Device Development, Clinical Development, Regulatory Affairs, Quality, and External Manufacturing teams to ensure device solutions are robust, scalable, regulatory‑compliant, and aligned with patient, clinician, and business needs.

Responsibilities:

Strategy & Leadership

Define and lead the medical device development strategy aligned with the company’s cell therapy pipeline and long‑term platform vision.

Act as a core leader for combination product development, ensuring strategic alignment across various technical areas.

Serve as the primary technical leader in governance forums.

Act as a thought leader in device‑enabled cell therapy delivery, monitoring emerging technologies, standards, and competitive approaches.

Produce Development Oversight

Lead integration of device options into an overall program strategy

In partnership with functional leadership, oversee device development activities including but not restricted to: user needs, design inputs/outputs, risk management, verification & validation, and design transfer

Ensure device designs are compatible with sterile, GMP, and scalable manufacturing environments while meeting international or region-specific standards.

Program Leadership

Drive integrated development plans and timelines ensuring execution across a matrixed organization

Partner with Regulatory Affairs to define and execute U.S. and global regulatory strategies for combination products (e.g., FDA CDRH/CBER interactions).

Support regulatory submissions including IND‑enabling device sections, IDEs, 510(k), PMA, De Novo, and combination product filings as applicable.

Partner with various stakeholders to ensure devices meet real‑world clinical workflows and adoption requirements

Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and applicable combination product regulations.

Minimum Requirements:

Advanced degree (MS, Ph.D., or equivalent) in Biomedical Engineering, Mechanical Engineering, Materials Science, or related discipline.
12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
Demonstrated success leading complex device programs from concept through commercialization.
Hands‑on experience with combination products, drug‑device or biologic‑device integrations strongly preferred.
Deep knowledge of medical device regulatory frameworks and design control requirements.
Track record of building and leading high‑impact technical teams.
Experience managing external development partners, CDMOs, and device vendors.
Strategic thinker with strong execution discipline
Collaborative, strategic leader who thrives in cross‑functional matrix organizations
Clear communicator with the ability to influence at executive and board levels

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.



The estimated compensation range for this position is $ 230,000.00 - $ 243,630.00 per year.

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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More about this job

Responsibilities

Lead the strategy and technical development of delivery devices for cell therapy combination products, overseeing design, risk management, verification, validation, and manufacturing readiness. Drive integrated program plans and regulatory strategies while coordinating cross-functional teams and external partners through clinical development and commercialization readiness.

Requirements

Requires an advanced degree in biomedical engineering, mechanical engineering, materials science, or a related discipline, plus at least 12 years of progressive medical device development experience and senior leadership experience. Candidates should have a record of leading complex programs through commercialization, strong knowledge of device regulations and design controls, and experience with combination products, teams, and external development partners.

Skills

Medical Device Development
Cell Therapy
Device Strategy
Program Leadership
Design Controls
Risk Management
Verification And Validation
Regulatory Strategy
FDA Regulatory Affairs
GMP Manufacturing
ISO 13485
ISO 14971
21 CFR Part 820
Cross-Functional Leadership
External Partner Management

Visa sponsorship

Not detected in the job text

Keywords

Medical Device Development
Combination Products
Cell Therapy
Biologics
Drug-Device Integration
Biologic-Device Integration
Device Development Strategy
Design Inputs And Outputs
Design Controls
Risk Management
Verification And Validation
Design Transfer
Sterile Manufacturing
GMP
Scalable Manufacturing
FDA CDRH
FDA CBER
IND
IDE
510(k)
PMA
De Novo
ISO 13485
ISO 14971
21 CFR Part 820
Regulatory Affairs
Clinical Workflows
Program Management
CDMOs
External Development Partners

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