Senior Regulatory Affairs Specialist - Stuttgart, Deutschland - Philotech

Philotech

Geprüftes Unternehmen

Stuttgart, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Philotech - We love Engineering: For more than 30 years we have been a strategic development partner in Germany, France, Spain and UK for our customers in the aerospace, defence, automotive, transportation and telecommunications industries. As a company of the Bertrandt Group, we stand for innovation and quality within our core competencies Software Engineering, Validation & Verification, Systems Engineering, Support Engineering, Functional Safety as well as IT & Embedded Security. Our experts accompany projects from conception through implementation to successful completion.
Senior Regulatory Affairs Specialist (M/F/d) Medical Technology (Ref.

Nr:
:

Location:
Böblingen

Your tasks:

Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of medical products
Participate in crossfunctional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy
Responsible for regulatory planning for new product introductions and product changes, and ensuring maintenance of global regulatory compliance
Responsible for product registration submissions/approvals as well as license renewals and updates for EU and further worldwide locations
Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed
Continuously analyze US, EU, and international regulatory requirements and initiate relevant design changes
Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements
Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations
Provide Regulatory support for Audit, IIA and CAPA

Your profile:

Bachelor or (not mandatory) Master degree/diploma in engineering or scientific discipline
Ideally 5 years ́ plus professional experience in regulatory affairs
Several years of experience in regulatory affairs in the medical technology sector
Strong experience creating global regulatory submission plans, submission file preparation and receiving submission approval (EU, USA, Canada, etc.)
Experience creating and maintaining technical documentation as well as responding to reviews made by Notified Bodies or Competent Authorities
In depth experience with evaluation of design, manufacturing, supplier changes
Working knowledge of regulatory standards (e.g. IEC 60601 series, IEC 62304, IEC 62366, ISO 14971)
Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
Solution and detailoriented; well organised and selfmotivated
Team spirit and good communication skills
Excellent written and oral communication skills in English, German skills advantagous

Our Offer:
Philotech stands for flat hierarchies, open communication, self-initiative and an appreciative working atmosphere. Flexible working hours, mobile working and 30 days of holiday support your work-life balance. In varied and demanding projects, you can participate in the development of forward-looking technologies and grow with new challenges. In our Philotech Academy, you also have access to an extensive range of further training opportunities.