Sr. Regulatory Affairs Specialist

vor 5 Monaten

Berlin, Deutschland Inari Medical Vollzeit

**Description**:
The Sr. Regulatory Affairs Specialist works under mínimal supervision supporting cross functional teams with regulatory strategy and execution of Inari devices and modifications focused on countries Outside the United States (OUS), including but not limited to the European Union (EU), United Kingdom (UK), Middle East, etc.

**Responsibilities**:

- Support development of regulatory strategy and preparation of submissions for Class I/II/III devices.
- Support multiple projects simultaneously, track timelines and establish contingency plans.
- Interact and liaise with local regulatory agency authorities for initial submission and follow up, local registrations and query resolution.
- Interact, liaise, and provide RA support to direct Inari personnel and Inari distributors in EU/OUS.
- Upload registrations and update registrations in EUDAMED.
- Support tender operations by timely supply of accurate regulatory documents.
- Support global advocacy efforts in monitoring regulation changes across regions.
- Suggest opportunities to add efficiencies to existing processes as part of RA department’s goals.
- Support complaint handling, post-market and vigilance reporting requirements, assist in field safety actions.
- Support RA functional area in the review and approval of Change Orders.
- Review and interpret local/regional regulatory rules as they relate to company products and procedures, testing or record-keeping and ensure that they are communicated to appropriate stakeholders.
- Follow changes of the EU/OUS regulatory landscape, identify impact to the company and support development of solutions to maintain regulatory compliance.
- Review promotional material and labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
Other incidental duties as appropriate.

**Qualifications**:

- Bachelor’s degree in a scientific field (life sciences, engineering) is preferred.
- A minimum of 5 years’ experience in preparing international product submissions in a medical device company is required or 3 years with an advanced degree.
- Experience with the EU Medical Device Regulation 2017/745 and standards (ISO 13485, ISO 14971, etc.).
- Multilingual. Fluent in English and German.
Ability to support multiple projects simultaneously.
- Detail oriented with well-developed writing and analytical skills.
- Excellent, proven interpersonal, verbal, and written communication skills.
- Ability to work autonomously with mínimal direction.

**For United States Applicants Only**:
Inari Medical E-Verify Poster (English and Spanish)
Inari Medical Right to Work Poster (English)
Inari Medical Right to Work Poster (Spanish)

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