Senior Manager, Regulatory Affairs
hace 3 días
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD® clinical research portfolio, our work in accelerated enrollment solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on - now and in the future.
Join Thermo Fisher Scientific as the Senior Manager of Regulatory Affairs and take charge of ensuring Regulatory Compliance across Europe. This pivotal role involves coordinating various products, including medical devices, chemicals, and in-vitro diagnostics.
As a senior leader, you will craft and implement regulatory policies, ensuring compliance with European regulations. You will also lead projects to drive business growth and minimize regulatory risks.
**Discover Impactful Work**:
A day in the Life:
- Develop and implement regulatory strategies for the European market, ensuring compliance with EU regulations for medical devices, pharmaceuticals, chemicals, and in-vitro diagnostics (IVDR).
- Offer strategic mentorship on regulatory matters and align regulatory strategies with corporate objectives.
- Ensure that all government-issued licenses and European and local accreditations are maintained and up to date across all operations.
- Develop and implement regulatory policies and procedures in compliance with European regulations.
- Identify and assess regulatory risks associated with European and global chemical regulations.
- Lead the preparation and compilation of regulatory submissions and annual government reporting.
- Coordinate approvals for new product introductions, including IVDR-regulated in-vitro diagnostic products.
- Act as the main point of contact for European regulatory agencies, the Thermo Fisher Corporate office, and internal collaborators.
- Stay updated on new and evolving European regulatory guidelines and policies.
- Support and lead preparation for internal and external audits.
**Desired Profile**:
- Established proficiency in leading Regulatory Affairs at a senior level, including handling complex projects and cross-functional teams.
- Extensive knowledge of European regulatory requirements for medical devices, chemicals, and in-vitro diagnostics (IVDR).
- Excellent interpersonal skills to engage with European Regulatory authorities, internal teams, and external partners.
- Extensive global regulatory affairs experience, including expertise in European and international chemical regulations, IVDR compliance, and directives like REACH and CLP.
**Education**:
- A Bachelor’s degree or equivalent experience in a field such as Life Sciences, Chemistry, or Engineering.
- Equivalent combinations of education and experience will be considered, with a focus on regulatory project management and compliance expertise.
**Experience**:
- Proven experience in Regulatory Affairs, particularly in Europe, with a strong background in leading chemical regulations and IVDR compliance.
- Experience in leadership of cross-functional regulatory projects and implementation of global regulatory strategies.
**Benefits**:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
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