Sr. Regulatory Affairs Specialist

Job Title: Sr. Regulatory Affairs Specialist
Location/Division Specific Information
Sweden
How will you have an impact?
Thermo Fisher is seeking an experienced Regulatory Affairs professional with IVD Regulation (EU) 2017/746 expertise, to join the exciting area of In Vitro Diagnostic and Clinical Research products as part of Thermo Fisher Scientific Life Sciences Solutions.
You will be part of the primary liaison group, at the forefront of the Company interactions with Competent authorities, in the region.
In addition, you will conduct global training for regulatory compliance, participate in process improvement projects, and assist with audits.
You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
You will continue to improve existing regulatory intelligence infrastructure that facilitates regulatory and business objectives by staying abreast of changes to relevant regulations and policies. Engage internal and cross-functional stakeholders by proactively outline and communicating risk and opportunities to regulatory strategies leading to internal policy development and alignment


What will you do?
Serve as a member of the EMEA Regulatory Affairs Shared Services department and will have direct line reporting to RA Manager and supporting Director of Regulatory Affairs/Clinical.
Function as a direct link between the Global and Local RA team members to ensure local and regional regulatory strategies are developed and aligned.
Act as subject matter expert regarding compliance to IVD Regulation (EU) 2017/746 and other EMEA IVD regulations.
Independently lead others and conduct regulatory assessments with minimal guidance or supervision
Influence all functions and levels in the organization to foster personal ownership of regulatory compliance.
Apply knowledge of device regulatory requirements in order to support sites in their successful conversion to IVDR compliance within defined regulatory timeframes.
Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, Health Canada, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
Participate in process improvement projects.
Supports process owners and global product manufacturing sites to address internal/external audit and inspection findings.
Responsible for SOP revisions/document creation/annual document review as assigned.
Review customer-facing communications as assigned.
Maintain current knowledge of international regulation, guidance and standards applicable to company products.


How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.



Experience Requirements:
· Must have a minimum of 5 years of IVD Regulatory Affairs experience, with expert knowledge of IVD Directive 98/79/EC and Regulation (EU) 2017/746.
· Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
· Direct and positive experience in communicating with Regulatory Authorities and internal partners.
· Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
· Capacity to communicate regulations to all functions including technical, within the company


Required Qualifications:


High energy level; positive attitude; detailed oriented; works well under stress
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Ability to provide solutions based on knowledge of regulation and industry experience
Willingness to travel (~10-15%)
Comfortable with ambiguity and change
Comfortable working within colleagues in different regions under tight timelines
Excellent knowledge-based PC computer skills essential
Understanding of medical terminology


Please note, there is a preferred candidate for this role.

http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.