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Regulatory Specialist – Medical Devices

Penumbra, Berlin, Germany

Innovative Medical Devices


# Innovation # Teamwork # Initiative # Open Communication are our common values. If you are looking for a meaningful challenge in a well-established international company and if you have a hands-on mentality – then join us and help us to save lives with your know-how and expertise. Be prepared for a career that doesn’t feel like work!

Penumbra Europe GmbH is based in Berlin, headquartered in Alameda, California. We are a global healthcare company focused on innovative therapies.  Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need.  Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

We are a dynamic and constantly growing company. As a result, we are looking in Berlin for an experienced Regulatory Specialist. As part of Penumbra’s Regulatory team, you will support an innovative and global company that develops ground-breaking technology to further its mission of saving patients’ lives. In this role you will work with the team and ensure that Penumbra products are approved for use in the EEMEA region. You will be responsible for the coordination, preparation and maintenance of document packages for worldwide regulatory submissions. This is more than a typical Regulatory Specialist position. In this role you will have the chance to create something, rather than to remediate.

What you'll work on

  • Assist in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as:  product approvals in the Middle East, North Africa, Central-Eastern Europe. This entails preparing submissions by retrieving information from Technical Documentation used for CE-marking and 510(k) clearance submissions, applying for Certificates to Foreign Government/Certificate of Free Sales Exportability, notarization/legalization activities. Supporting reimbursement activities by collating relevant clinical & cost benefit information
  • Support the legal manufacturer in CE-marking projects and conformity assessment procedures for the EU
  • Ensure that existing approvals and documentation are maintained
  • Communicate with in-country Regulatory Affairs personnel to facilitate global clearances and approvals
  • Support the creation, translation and review of labeling, Instructions for Use, and promotional materials
  • Analyze existing systems and procedures, recommending improvements as needed
  • Support the development of Work Instructions and SOPs as needed to support departmental functions and the Quality System
  • Develop a working understanding of the Quality System, biocompatibility requirements, Design Control, Medical Device Regulation, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, export requirements and regulatory requirements of pertinent regions

What you bring

  • A minimum of 2 years’ relevant work experience in regulatory affairs, quality assurance, clinical affairs or a related field - preferably in the medical device or biotechnology industry
  • A Bachelor’s degree in a science or engineering discipline such as biology, neuroscience, chemistry or biomedical engineering
  • Proficiency in English. Another language like Arabic or Russian is a plus
  • Excellent ability to write concise and strategic technical documents
  • Demonstrated ability to drive solutions and resolve issues creatively
  • You have excellent organization skills and you are able to prioritize and meet deadlines in timely manner
  • You are flexible, open-minded and you have excellent intercultural skills
  • Last but not least, you are an excellent team player and thrive when faced with challenges

What We Offer

  • A permanent and full-time position; fantastic public transport connections; a free parking spot or a subsidy for public transportation and a gym membership for free
  • Employee stock purchase plan
  • Possibility to work remotely during covid-19
  • The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases
  • The ability to work amongst a professional, dynamic and vibrant global team with friendly, highly qualified colleagues
  • Internationally established company with a hands-on mentality, strong emphasis on a diversity culture, positive intercultural environment with over 30 nationalities in our Berlin office
If you are interested in this position, please do not hesitate to apply now. We'd love to hear from you! Jamila Zarra (EMEA Senior Recruiter) will come back to you asap.

Your application will be treated in a confidential, professional and ethical manner.
 
- Requests from Recruitment Agencies will not be answered -

About Penumbra

PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Penumbra

Want to learn more about Penumbra? Visit Penumbra's website.