Regulatory Affairs Specialist at Danaher Corporation

Portsmouth, England, United Kingdom

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Healthcare, Medical DevicesIndustries

Requirements

Life Sciences degree or equivalent
At least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field
Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971
Experience with Quality Management System documentation
Ability to communicate effectively across all departments and functions
Good attention to detail
Excellent English oral and written communication
The ability to present technical, product and regulatory information clearly and concisely
Ability to travel required at 10% or less within the EMEA region

Responsibilities

Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices
Submit Technical Documentation to Notified Bodies for review and approval
Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls
Support medical device Regulatory Intelligence process and customer requests
Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices
Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager

Skills

Regulatory Affairs

Medical Devices

EU MDR 2017/745

Technical Documentation

Notified Bodies

QMS

Vigilance Reports

Regulatory Intelligence

UK MDR 2002

Life Sciences

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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