Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
Requirements
- Advanced education and specialized knowledge in regulatory affairs (typically acquired through advanced education)
- Experience as an individual contributor in a professional discipline or specialty, with ability to work independently with general supervision on larger, moderately complex projects/assignments
- Understanding of regulatory procedures, changes, and compliance requirements, particularly for medical devices, drugs, and combined products in Canada (Health Canada)
- Ability to set objectives for own job area, contribute to project milestones, and make adjustments/recommendations to systems and processes
- Strong communication skills for internal collaboration (e.g., with Marketing, Global Regulatory Teams, Business Units) and external interactions with regulatory agencies (less complex problem-solving)
- Ability to maintain professional relationships with regulatory agencies like Health Canada
- Capacity to mentor colleagues or direct lower-level professionals (may apply)
Responsibilities
- Evaluate, develop, and recommend strategic submission pathways, options, and strategies for departmental assignments
- Prepare medical device applications and combined product submissions to meet regulatory agency requirements, ensuring follow-up until approval
- Direct or perform coordination and preparation of document packages for regulatory submissions, internal audits, and inspections
- Lead or compile materials for submissions, license renewals, and annual registrations
- Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance
- Monitor and improve tracking/control systems
- Keep abreast of regulatory procedures and changes
- Direct interaction with regulatory agencies on defined matters
- Recommend strategies for earliest possible approvals of clinical trials applications
- Report complaints and Adverse Drug Reactions (ADR)
- Maintain ongoing dialogue with business partners to develop strategies aligned with the business plan
- Liaise with Business Unit to obtain product and technical documents for preparing license applications for filing in Canada
- Ensure timely completion of regulatory submissions, applications, and related amendments
- Maintain professional relationship with Health Canada
- Ensure all regulatory records/documents are properly maintained in accordance with regulatory requirements and internal processes
- Support or lead special Regulatory business projects and assignments as required
- Collaborate with Marketing and Global Regulatory Teams to assess and prioritize submissions to Health Canada
- Participate in product launch activities as required
- Ensure compliance with government regulations by providing Health Canada with necessary technical information on changes or modifications to regulated medical products (e.g., Drugs, Devices, CTO)
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this a remote position or does it require office work?
This information is not specified in the job description.
What is the salary or compensation for this Regulatory Affairs Specialist role?
This information is not specified in the job description.
What are the key responsibilities and skills needed for this role?
The role involves evaluating and recommending strategic submission pathways, preparing medical device applications for regulatory agencies like Health Canada, coordinating document packages for submissions, recommending changes for compliance, and maintaining relationships with regulatory bodies. Typically requires specialized knowledge in regulatory affairs for medical devices, project management skills, and ability to liaise with business units and global teams.
What is the company culture like at Medtronic?
Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity, while breaking down barriers to innovation in a connected, compassionate world.
What makes a strong candidate for this Regulatory Affairs Specialist position?
Strong candidates are individual contributors with specialized knowledge in regulatory affairs, experience managing projects from design to implementation, ability to collaborate with stakeholders like marketing and global teams, and skills in maintaining professional relationships with agencies like Health Canada.
Medtronic
Develops and manufactures medical devices and therapies
About Medtronic
Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.
Fridley, MinnesotaHeadquarters
1949Year Founded
$3.2MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees