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Medical Device Regulatory Assistant
2 months ago
**Responsibilities**:
- Collaborate with cross-functional teams to support regulatory compliance efforts for medical devices.
- Assist in the preparation and submission of regulatory documents to relevant authorities, ensuring adherence to ISO 13485, MDSAP, CE, and FDA standards.
- Maintain and update regulatory databases and documentation to ensure accuracy and completeness.
- Participate in internal and external audits to ensure compliance with regulatory requirements.
- Stay abreast of changes in regulatory guidelines and requirements, and communicate these changes to the relevant teams.
- Contribute to the development and implementation of regulatory strategies for new and existing medical devices.
- Support the creation and maintenance of technical files and documentation for product registration and approvals.
- Assist in preparing responses to regulatory inquiries and requests.
**Requirements**:
- Previous work experience in regulatory affairs within ISO certified companies is mandatory.
- A minimum of 2 years of relevant experience in a similar role.
- Medical device experience is necessary; an understanding of medical device classifications and regulations is essential.
- Detail-oriented with the ability to work both independently and collaboratively within a team environment.
- Bilingual proficiency in English and French (written and spoken) is an asset but not required.
- Minimum college education or Accredited Certificate program preferred, with certifications in ISO 13485, MDSAP, CE, and/or FDA regulations.
- Strong organizational skills and the ability to multitask effectively.
- Excellent interpersonal, verbal, and written communication skills, including a strong command of grammar and composition.
- Demonstrated initiative, good judgment, and problem-solving abilities.
- A positive attitude, disciplined work ethic, and a keen desire to learn and take on new challenges.
**Job Types**: Full-time, Permanent
**Salary**: $45,000.00-$50,000.00 per year
**Benefits**:
- Dental care
- Disability insurance
- Life insurance
- Paid time off
- Vision care
Schedule:
- Monday to Friday
Work Location: Remote
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