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Työnimike: Muu kemisti

Työnkuvaus:
Position - Regulatory Affairs Manager, Labsystems Diagnostics, Finland

Responsibilities:

Prepare product related technical documentation
Ensure that quality standards are met and submissions meet strict deadlines
Liaise and negotiate with regulatory authority
Plan, undertake and oversee product trials and regulatory inspections
Identify and communicate relevant guidance, policies, standards, and regulations
Outline requirements for labelling, storage and packaging
Analyse products related technical information, including trial data
Maintain familiarity with company product ranges
Support regulatory compliance initiatives
Support supplier engagement teams and perform external due diligence regulatory activities
Maintain effective relationships with internal and external stakeholders
Support the development. implementation and maintenance of IVD products regulatory processes
Lead and perform internal policy reviews for global regulatory guidance and regulations
Contribute to and participate in internal and external education and training activities

Skills & Qualifications:

Masters in Science or Ph.D. degree in Chemistry, Biochemistry, Microbiology or a similar field
Excellent communication skills - oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Demonstrated ability to contribute to a continuous learning and process improvement environment
Fluent in English and some proficiency in Finnish will be an advantage
Good reporting and presentation skills
Familiarity with the new European IVD Directive
Focused ability to influence operational excellence and performance metrics
Knowledge of MS Office tools, and technology related software

Competencies

Knowledge of Medical Devices/IVD regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion, Labelling, Launch and Commercialization
Familiarity with Regulatory Authority policies and guidance and apply them as appropriate in product development and labeling regulatory activities
Ability to plan for new products a successful product regulatory strategy along with the R & D and Marketing teams for a successful regulatory approval
Review detailed scientific information and assess whether technical arguments and conclusions are adequately supported by data
Ability to assess project risks, recommend contingency plans to mitigate regulatory risks
Business orientation and ability to see the business drivers outside of Regulatory Affairs

Sameer Saral, Puh: +358504406704, sameer.saral (at) labsystemsdx.com

numberOfPosts: 1

euresFlag: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2113

abstractJV_contact_0:
sameer.saral (at) labsystemsdx.com
Phone 0504406704

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Työnantajan nimi: Labsystems Diagnostics Oy

source: TIVA