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Regulatory Affairs Specialist, EU MDR

Apply Now Job ID R-329309 Date posted 02/16/2019

Job Description Summary

Job Description

The EU MDR Regulatory Affairs Specialist will be responsible for supporting of a variety of regulatory activities and projects with oversight from senior regulatory staff.  

This position is through 12/31/20. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BD.

Responsibilities include tracking technical file remediation efforts and related regulatory project activities.   The scope of the position will include support of BDI surgery EU MDR program for surgery platforms. for IVD and Research product portfolios. 

Activities include but are not limited to the following:

  • Organization/management of EU technical files, tracking progress against submission deadlines, coordination activities for procedures and organization of regulatory documents and data.   
  • The RA Specialist will work on problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.
  • Coordinates and supports the preparation and maintenance of moderately complex regulatory submissions/files including EU technical files, U.S. FDA submissions and international dossiers (eGPS) required for worldwide registrations.
  • Monitors worldwide laws and regulations through websites and publications, and identifies and communicates items needed for interpretation for impact to BDB regulated products.  He/she will also provide comments to staff/senior RA associates for inclusion in BDX responses to regulators and other agencies.
  • Supports updates to technical file documentation and ensures consistency across a variety of BDI technical documentation
  • Assists in implementing department procedures and maintaining regulatory requirements matrices as applicable
  • Provides support to EU MDR functional EU MDR  teams and performs other related duties and assignments as required.  

Qualifications

Minimum Qualifications:

  • Experience updating technical files and global design dossiers is a requirement
  • Knowledge of the Medical Device Directive and Medical Device Regulation is a requirement
  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.  
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
  • Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results
  • Excellent interpersonal skills, ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal).  This includes excellent written and verbal communication skills
  • Computer literacy (Microsoft Word / Excel / PowerPoint, Document Management and Change Control Systems)
  • Detail oriented, with emphasis on accuracy and completeness

Education and Experience:

  • B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.),
  • 1-2 years minimum familiarity with regulatory requirements for a medical device or drug establishment legal manufacturer such as listings, establishment registrations, Design History Files, Device History Records and Design controls.
  • Experience tracking program metrics or project management desired
  • UDI and global labeling requirements preferred
  • This position does not provide relocatoin assistance

Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

NA (United States of America)
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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com