regulatory affairs specialist in Oberdorf

posted
contact
Audrey Bisch, Basel Professionals Health Care & Life Sciences
job type
contract
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job details

posted
location
oberdorf, nidwalden
sector
life sciences
job type
contract
reference number
16325
contact
audrey bisch, basel professionals health care & life sciences
phone
058 201 55 50

job description

Do you want to work in a medical device company ? Do you have at least 4 years experience in Regulatory Affairs ? You should then read the following lines!

Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission until the end of the year with strong possibility for extension 

 

OVERALL RESPONSIBILITIES:

Support MDR compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices to comply with MDR requirements

 

POSITION DUTIES & RESPONSIBILITIES:

• Identify, create and/or update reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Table of Contents, Declaration of Conformity, and labeling.

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.

• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.

• As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.

• Identify and adhere to policies, procedures and work instructions which support technical documentation activities

• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials

• Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan

• Support for routing and implementation of the remediated documents in PLM systems

• Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required

• Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned

• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations

 

EXTENDED DUTIES:

• Follow the quality standards and regulatory requirements

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times

• Resolving complex issues as they arise

 

PROFESSIONAL EXPERIENCE REQUIREMENTS:

• At least 5 years of experience in European Medical device as regulatory affairs specialist

• Strong knowledge of ISO 13485 and ISO 9001, QSR,

• understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)

• MEDDEV guidance documents applicable to Medical Devices products and processes

• Strong understanding of Risk Management process, label and labeling, change management is desired

 

EDUCATIONAL REQUIREMENTS:

• Master’s Degree in engineering or life sciences is required;

 

LANGUAGE:

• English fluent is mandatory (all documentation in English)

 

OTHER REQUIREMENTS:

• Strong knowledge and skills in MS Office

• Familiarity with Technical Documentation structure according to STED required

• Strong interpersonal and diplomatic skills

• Team work oriented, within a multi-functional and multi-national team

• Customer / service orientation

• High analytical, planning and organizational skills; able to set priorities

 

Do not waste any minutes, apply now!  We are looking forward to receiving your application.