Principal Regulatory Affairs Specialist Medical Devices (m/w/d) - Schwerpunkt Schweiz
Core
Principal Regulatory Affairs Specialist ensuring regulatory compliance for Boston Scientific's medical device portfolio across Central/Western Europe with a specific focus on the Swiss market.
Role type
Principal Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory compliance and market access for medical device products
Domain
Medical Devices / Healthcare Regulatory Affairs
Deliverable
client delivery
Required skills
Swiss medical device regulations expertise, European regulatory framework knowledge, stakeholder relationship management, audit and inspection support, process optimization, cross-functional collaboration
Preferred skills
Industry landscape understanding, matrix environment experience, quality system compliance knowledge
Technologies
Swissdamed
Responsibilities
Manage relationships with national regulatory authorities, ensure regulatory compliance for product portfolio, serve as primary regulatory contact for Switzerland including Swiss Importer/Authorized Representative duties, support audits and inspections, optimize regulatory processes, represent company in trade associations
Seniority
Principal, strategic execution & regional leadership