Key skills
Project Management
About this role
Role Overview
- Taking responsibility for certification and conformance of 3M Fall Protection products to applicable EN/CE standards.
- Identifying the regulatory product certification requirements for assigned Personal Protective Equipment (PPE) portfolios and geographies.
- Preparing, maintaining and submitting regulatory documentation for product certification schemes applicable to PSD’s product portfolio in division and corporate systems.
- Actively working with appropriate test labs, notified bodies, and agencies to submit products for certification, accelerate the registration process, and arrange manufacturing site audits as required to ensure conformance of products.
- Collaborating with business portfolio leader(s), application engineers, quality, manufacturing and other cross functional roles to provide regulatory/compliance input into PSD new product projects and conduct regulatory assessments for new products during the commercialization process.
- Engaging with regulatory authorities, notified bodies, or agencies with any post-market follow-up activities or issues.
- Performing routine regulatory tasks for new and existing products.
- Keeping abreast of changes in all applicable standards and regulations/directives.
Requirements
- Fluent in English and Slovak
- Bachelor's degree or higher (completed and verified prior to start from an accredited institution)
- Experience in a regulatory affairs (e.g. ppe, pharmaceutical, medical devices, automotive) or related role in a general manufacturing, environmental compliance, or quality experience
- Knowledge of standards and regulatory framework relating to chemicals, pharmaceuticals, medtech, PPE and fall protection is desirable
- Working experience in multinational companies
- Strong interpersonal skills and able to build internal and external networks and communicate effectively
- Mechanical aptitude
- Self-starter who can effectively work in a fast-paced environment, with an appropriate sense of urgency
- Strong organizational skills (prioritization, project management)
- Ability to work well alone and in diverse teams
- Analytical and problem-solving skills
- Eye for detail
Benefits
- yearly bonus (Annual Incentive Plan)
- excellent benefits package