Sales Admin & Compliance Specialist at Zalaris managing sales processes and ensuring contract compliance. Supporting the sales team with document management and CRM development.
About the role
- Regulatory Affairs Manager leading regulatory submissions for medical device company. Ensuring compliance with global regulations and facilitating market access for products.
Responsibilities
- Develop and execute regulatory strategies for new product introductions and product lifecycle management.
- Prepare, review, and submit regulatory filings (e.g., 510(k), PMA, CE Mark, etc.) to regulatory agencies worldwide.
- Act as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and inspections.
- Interpret and apply complex regulatory requirements to product development, manufacturing, and marketing activities.
- Conduct regulatory assessments for design changes, manufacturing changes, and labeling updates.
- Manage and maintain regulatory licenses, registrations, and approvals.
- Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs.
- Monitor and analyze evolving global regulatory landscapes, assessing potential impacts on products and processes.
- Participate in internal and external audits to ensure compliance with quality system regulations (e.g., ISO 13485, 21 CFR Part 820).
Requirements
- Bachelor's degree in a scientific, engineering, or related field; advanced degree (Master's or Ph.D.) preferred.
- Minimum of 5-7 years of experience in Regulatory Affairs within the medical device industry.
- Demonstrated success in preparing and obtaining regulatory approvals (e.g., FDA 510(k), PMA, CE Mark).
- In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR, Health Canada, TGA, MHLW).
- Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820).
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- RAC (Regulatory Affairs Certification) preferred.
- Proficiency in Microsoft Office Suite and regulatory submission software.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible working arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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