Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Who You Will Be Working For
Join a leading organization dedicated to improving healthcare standards by ensuring its medical devices and drugs meet the highest regulatory standards. This company operates in Canada the U.S. and internationally providing innovative solutions to healthcare challenges. Known for fostering a collaborative and inclusive environment the company supports its employees growth while maintaining a strong commitment to quality and compliance.
As the Regulatory Affairs Manager you will report to the Vice President of Quality Assurance and Regulatory Affairs (QA/RA) and lead the companys regulatory activities. Your role will ensure the organizations compliance with all relevant regulatory standards across Canada the U.S. and Europe. The primary focus of this position will be project management with key internal and external partners. Developing regulatory pathways for Medical Device/Drug Combination Kits with the FDA Health Canada and may include the EU MDR.
- Managing regulatory activities to secure and maintain medical device registrations compliant with Canadian U.S. and European regulations.
- Acting as the regulatory subject matter expert guiding team members and crossfunctional partners.
- Developing and implementing regulatory strategies for product registration and lifecycle management.
- Leading the preparation of regulatory submissions including FDA 510(k) applications and Canadian Medical Device License applications.
- Collaborating with internal and external stakeholders to align regulatory strategies with business objectives.
- Managing customer complaints to comply with regulatory requirements.
- Supporting audits regulatory visits and ensuring compliance with ISO 13485 and other relevant standards.
- This role may have direct reports in the future.
Requirements
Requirements for Success
EDUCATION & TRAINING
- Bachelor s degree (B.Sc.) in a biological science or related field.
- 5 years of experience in regulatory affairs preferably within the healthcare industry.
- Experience directly/indirectly managing a team is preferred.
- Comprehensive knowledge of Canadian Medical Device Regulations (MDR) U.S. FDA regulations European MDR and ISO 13485 standards.
- Strong technical writing analytical and problemsolving skills.
- Proficiency in Microsoft desktop applications and project file preparation.
- Excellent interpersonal and communication skills to foster collaboration across all levels of the organization.
- Ability to work in a fastpaced dynamic environment while managing multiple priorities.
Benefits
What You Can Expect In Return
- A Collaborative Culture: Work with a team dedicated to innovation and regulatory excellence.
- Competitive Compensation: A 612 month contract and salary aligned with your expertise. There may be an opportunity for a permanent position.
- Meaningful Impact: Contribute to the success of medical devices that enhance lives globally.
WORK EXPERIENCE & ACCOMPLISHMENTS -5+ years of experience in regulatory affairs, preferably within the healthcare industry. -Experience directly/indirectly managing a team is preferred. -Comprehensive knowledge of Canadian Medical Device Regulations (MDR), U.S. FDA regulations, European MDR, and ISO 13485 standards. SKILLS & COMPETENCIES -Strong technical writing, analytical, and problem-solving skills. -Proficiency in Microsoft desktop applications and project file preparation. -Excellent interpersonal and communication skills to foster collaboration across all levels of the organization. -Ability to work in a fast-paced, dynamic environment while managing multiple priorities.
Education
Bachelor s degree (B.Sc.) in a biological science or related field.
Employment Type
Full Time
