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Regulatory Affairs Specialist - Senior
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Engineering, Plm
Projektbeschreibung
For our client in ZUCHWIL we are looking for a REGULATORY AFFAIRS SPECIALIST - SENIOR for a 12-MONTH contract.
JOB TITLE: REGULATORY AFFAIRS SPECIALIST - SENIOR
DURATION: 10/12/2018 TO 31/12/2019
LOCATION: ZUCHWIL
WORKLOAD: 100%
DESCRIPTION:
Project name: MDR RA-Tech Files
- Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR)
- Provide regulatory support for New Project Development projects as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k)
- Provide regulatory support for Life Cycle Management project as assigned
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
- Perform Regulatory Change assessments as assigned,
- Perform Labeling and Promotional Material Reviews as assigned.
MUST HAVES:
* At least 4 years of experience in Medical Device Industry and Regulatory Affairs.
. Understanding of MDR requirements regarding required content of Technical Documentation
(focus on ANNEX II of Regulation (EU) 2017/745)
. Understanding of requirements of current Council Directive 93/42/EEC
. Previous experience within Regulatory Affairs at DePuy Synthes preferred
. Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
. Experience in IT system documentation and database management preferred
. Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
. Ability to comprehend principles of engineering, physiology and medical device use.
. Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.
SOFT SKILLS:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
For further details please contact:
Anna Undas
(see below)
JOB TITLE: REGULATORY AFFAIRS SPECIALIST - SENIOR
DURATION: 10/12/2018 TO 31/12/2019
LOCATION: ZUCHWIL
WORKLOAD: 100%
DESCRIPTION:
Project name: MDR RA-Tech Files
- Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR)
- Provide regulatory support for New Project Development projects as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k)
- Provide regulatory support for Life Cycle Management project as assigned
- Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
- Perform Regulatory Change assessments as assigned,
- Perform Labeling and Promotional Material Reviews as assigned.
MUST HAVES:
* At least 4 years of experience in Medical Device Industry and Regulatory Affairs.
. Understanding of MDR requirements regarding required content of Technical Documentation
(focus on ANNEX II of Regulation (EU) 2017/745)
. Understanding of requirements of current Council Directive 93/42/EEC
. Previous experience within Regulatory Affairs at DePuy Synthes preferred
. Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
. Experience in IT system documentation and database management preferred
. Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
. Ability to comprehend principles of engineering, physiology and medical device use.
. Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.
SOFT SKILLS:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
For further details please contact:
Anna Undas
(see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges