- Technical Writing
- ISO 9001
- ISO 13485
Organize and chair meetings to evaluate internal and external product problems and to determine if Field (Safety) Corrective Actions are necessary. Create Field (Safety) Corrective Action Notifications and supporting documentation.
Evaluate complaints and determine if Vigilance Reporting requirements apply within regulatory timelines. Complete the applicable vigilance records and obtain appropriate approval of the decision (MDRs to CDRH, Biologics Reports to CBER).
Create and manage the completion of Post Market Surveillance (PMS) reports as assigned.
Assist sites in the completion of the Corporate QMS indicators and definition of the action plans.
Assist in the execution and improvement of regulatory processes.
Prepare responses to and interact with regulatory agencies as required.
Participate in and provide support for regulatory and Notified Body audits/inspections and assist in customer audits.
Participate and lead global cross-functional teams and projects as assigned.
Monitor and maintain familiarity with applicable regulations, and assist with the review and revision of bioMérieux procedures.
Train/mentor colleagues/peers in relation to departmental objectives and responsibilities.
Bachelor of Science degree in Engineering or related field of study; advanced degree preferred
Knowledge of FDA 21 CFR 806 & 803, MEDDEV Vigilance, QMS requirements (21 CFR 820 and ISO 13485 / ISO 9001) and regulatory submission types (local/regional)
8-10 years experience in related medical devices, pharmaceutical, or healthcare industries
Knowledge of compliance requirement, guidance documents, and responses (local and regional) with 2-5 years of practice in the field of IVD/MD in an international environment.
Developed knowledge of Vigilance Guidance Documents, FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR820 and ISO 13485), change controls and submission types
Skills and Qualifications:
Analyze and understand technical and scientific documents, and governing regulatory research information and data
Attention to details, thoroughness and consistency a must.
Excellent writing skills, including consistent and thorough technical writing skills
Can communicate effectively with all levels within the organization.
Exhibits strong working relationships and encourages an environment of teamwork
Works well in an international environment, exhibiting good communication skills with internal stakeholders both verbally and in writing
Possesses strong ability to lead global cross-functional meetings.
Familiar with product profiles and technologies
Familiar with local regulatory agency organization and processes
Participate in local professional/trade associations, such as ASQ
Develop rationale and justify position to support recommendations and decisions
Communicate to internal stakeholders, regulatory agencies and conformity assessment body
Exhibits a positive attitude and a willingness to consider creative solutions to challenges
Possesses experience with various office software packages, spreadsheets, programs and systems
Travel: Must possess an interest in and willingness to travel domestically and internationally an average of 10% of time.
bioMerieux is an Equal Opportunity Employer/Affirmative Action Employer M/F/Vet/Disability/Sexual Orientation/Gender Identity
: AMER-AMER-US-MO-St. Louis, MO
: Oct 24, 2018, 10:57:27 PM
: Day Job
: Yes, 10 % of the Time