Global Regulatory Affairs Specialist (Life Sciences)
Serana Europe GmbH, New Bremen, OH, United States
We are seeking a
Regulatory Affairs Specialist
to support regulatory compliance and market access for life science products. This role involves managing regulatory processes, preparing documentation, and ensuring adherence to applicable regional and international regulations. Key Responsibilities Prepare and maintain
regulatory documentation and technical files Ensure compliance with
applicable regulations and standards
(e.g., EU, FDA, ISO) Lead and support
product registrations, submissions, and approvals Monitor regulatory changes and assess impact on products Collaborate with cross-functional teams including
R&D, Quality, and Manufacturing Support audits, inspections, and authority interactions Qualifications Degree in
Life Sciences, Biotechnology, Chemistry , or related field Proven experience in regulatory affairs within the
life sciences, biotech, or medical device industry Demonstrated track record of successful regulatory approvals for relevant products Knowledge of
global regulatory frameworks
and quality standards Native or fluent German and good working proficiency in English Strong organizational skills and attention to detail Effective communication and stakeholder management abilities Preferred Experience with
international product registrations Familiarity with
ISO standards (e.g., ISO 13485) Understanding of
biological or pharmaceutical products
#J-18808-Ljbffr
Regulatory Affairs Specialist
to support regulatory compliance and market access for life science products. This role involves managing regulatory processes, preparing documentation, and ensuring adherence to applicable regional and international regulations. Key Responsibilities Prepare and maintain
regulatory documentation and technical files Ensure compliance with
applicable regulations and standards
(e.g., EU, FDA, ISO) Lead and support
product registrations, submissions, and approvals Monitor regulatory changes and assess impact on products Collaborate with cross-functional teams including
R&D, Quality, and Manufacturing Support audits, inspections, and authority interactions Qualifications Degree in
Life Sciences, Biotechnology, Chemistry , or related field Proven experience in regulatory affairs within the
life sciences, biotech, or medical device industry Demonstrated track record of successful regulatory approvals for relevant products Knowledge of
global regulatory frameworks
and quality standards Native or fluent German and good working proficiency in English Strong organizational skills and attention to detail Effective communication and stakeholder management abilities Preferred Experience with
international product registrations Familiarity with
ISO standards (e.g., ISO 13485) Understanding of
biological or pharmaceutical products
#J-18808-Ljbffr