Regulatory Affairs Professional - Putzbrunn, Deutschland - W. L. Gore & Associates

W. L. Gore & Associates

Geprüftes Unternehmen

Putzbrunn, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Job:
Clinical/Regulatory

Primary Location:
Europe-DE-BY-Putzbrunn

Other Locations:
Europe-FR-IDF-Paris, Europe-DE-BY-Pleinfeld, Europe-IT-34-Verona, Europe-ES-CT-Barcelona, Europe-SE-O-Mölndal, Europe-GB-SCT-Edinburgh, Europe-NL-NB-Tilburg, Europe-GB-SCT-Dundee

Travel%: 15%

Shift:
Day

Schedule:
Full-time

Regulatory Affairs Professional (f/m/d) (Post-Market Compliance) - Home Office

-

231023
This position may be located in Europe or the United States.

About Us:

Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.

About the Role:

We are looking for a Post-market Regulatory Affairs Associate (f/m/d) to join our Regulatory Affairs Team in the United States or Europe who will provide regulatory support to post-market functional teams and other stakeholders.

This is a remote position, and you can work from your home office in most locations within various European countries.

Responsibilities:

Implement and update internal Post-Market Surveillance procedures to ensure compliance to applicable regulations
Obtain, interpret and implement domestic and international Post Market Surveillance medical device regulations
Perform gap analyses and update internal standard operating procedures and systems to be compliant in the event of changing regulations
Provide regulatory guidance for product surveillance coordinators in evaluating and reporting adverse events to applicable countries
Identify regulatory opportunities for training, system enhancements, and process harmonization
Support audits and develop strategic responses and corrective actions to audit findings
Contribute to improved functional effectiveness by supporting the development and/or use of standardized best practices, processes and tools
Partner with other project teams, regional teams and across the regulatory function to meet business needs to maintain post market compliance
Maintain compliance with training expectations as required for this position
Perform additional responsibilities as required within the scope of position

Required Qualifications:

Bachelor's degree
Minimum 2 years of experience with postmarket surveillance requirements in the medical device industry
Knowledge of FDA and international regulations related to postmarket surveillance of medical devices
Good communication (oral, written, and interpersonal skills)
Strong attention to detail
Good organizational skills
Ability to interact effectively with many diverse functional groups
Ability to prioritize work and adapt to shifting priorities
Ability to travel up to 15%, including internationally

Desired Qualifications:

Bachelor's degree

in a biological, chemical, engineering, medical, legal or allied health sciences field

Experience with postmarket surveillance requirements, including proactive surveillance, complaint handling or field actions, in the medical device industry
Experience with global post market adverse event reporting and/or medical device field actions
Remote Working Arrangements are permitted for Associates, with prior appropriate approval and compliance with Gore's remote working policies and additional documents, from the country in which they are employed.

We believe in the strength of a diverse workforce and inclusive work environment.

In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.

Our Talent Acquisition Team welcomes your questions at or toll-free at