BioSpace · 3 days ago
Senior Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics (Remote)
Mettawa, IL
Full-time
Remote
Senior Level, Lead/Staff
8+ years exp
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Responsibilities
Develops and prepares pre-market regulatory experience in IVD industry device regulatory product strategies and identifies data and information requirements. Seeks expert advice and technical support as required for strategies and submissions. Make decisions and provide guidance for supporting medical devices and combination products.
Manages the preparation and management of regulatory applications for devices and combination products, including new investigational applications and amendments, device technical files for pre-market notification and approval, and post-approval change applications. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
Manage products and change control in compliance with regulations and company policies and procedures. Analyzes and approves change management requests.
Develop device strategies for meetings with regulatory agencies and manage the content and preparation of information packages for pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
Regularly informs regulatory management of important timely issues.
Develops and implements policies and procedures within the regulatory affairs department.
Analyzes legislation, regulation, and guidance and provides analysis to the organization.
Represents RA Device on product development teams and design control teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
Represents RA Device on project initiatives with other groups to drive efficiencies across the company.
Qualification
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Required
Bachelors degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
8+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products.
5+ years in quality systems or cross-functional project management.
Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.
Experience working in a complex and matrix environment.
Strong communication skills, both oral and written.
Preferred
Relevant advanced degree preferred.
5+ years of pre-market regulatory experience in IVD industry.
10+ years biopharmaceutical experience in R&D, Quality, or Manufacturing supporting devices and drug/device combination products.
Experience developing and implementing successful global regulatory strategies.
Experience working with Health Authorities.
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
11-50 employees
H1B Sponsorship
BioSpace has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO and President
K
Kristin Jones
Chief Revenue Officer
Recent News
2024-12-11
2024-12-05
Company data provided by crunchbase
