Regulatory Specialist III
Thermo Fisher Scientific Näytä kaikki työpaikat
- Suomi
- Vakituinen
- Täyspäiväinen
- Develops and implements regulatory strategies for new and modified products.
- Plans, coordinates and prepares document packages for global regulatory submissions.
- Acts as company representative, developing and maintaining positive relationships with authorities through oral and written communications regarding submission pathway development, clarification, and follow-up of submissions under review.
- Acts as a core team member on product development, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Preparation and maintenance of product technical files for CE marking
- Maintaining trackers for Vantaa site
- Review/approve change orders
- Reviews product and manufacturing changes for compliance with applicable regulations and submits change notifications when applicable.
- Builds and implements departmental policies and procedures.
- Supervising/supporting Vantaa RA staff development
- Lead, motivate and guide associates in a matrix organization on industry-leading practices.
- Advise the business unit regulatory teams on the optimal regulatory strategies, submissions, and approval pathways. Manage a complex and diverse set of registration/regulatory requirements across global markets to enable the product global registrations.
- Work across business units to establish best practices, efficiencies, and development for regulatory affairs.
- Partner with R&D, marketing, operations, and business leadership for delivering on agreed timelines and global commercialization approaches. Create strong and proactive relationships with cross-functional functions.
- Interact with Notified Bodies, FDA, & global regulatory authorities to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications. Remain well-versed in evolving global regulatory policies and advise business units internally on anticipated changes, net business effect and develop appropriate strategies/processes to appropriately address.
- Oversee regulatory communications with marketing to ensure appropriate approval of commercial literature and language.
- Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in regulatory affairs in the pharmaceutical, medical device, or diagnostics industry
- Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field
- Additional certifications like RAC (Regulatory Affairs Certification) advantageous
- Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations
- Experience preparing and submitting regulatory filings (e.g., 510(k), CE marking, technical files)
- Demonstrated success in regulatory strategy development and implementation
- Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles
- Excellent project management skills with ability to manage multiple projects simultaneously
- Strong analytical and problem-solving capabilities
- Clear written and verbal communication skills
- Experience working effectively in cross-functional team environments
- Fluency in English required; additional languages beneficial
- Proficiency with regulatory submissions software and Microsoft Office suite
- Experience with change control and post-market surveillance activities
- Strong attention to detail and organizational skills
- Ability to interpret and apply complex regulatory requirements
- Customer-focused mindset with business acumen
- Available for occasional travel (10-20%)
- Effective interpersonal skills and ability to build consensus
- Experience supporting regulatory staff development preferred