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Regulatory Affairs Staff Specialist

  • Ubicación:

    Kelberg, Alemania

  • Contacto:

    Michael Rownicki

  • Tipo de trabajo:

    Contract

  • Teléfono de contacto:

    +353 21 485 7227

  • Industrias:

    Medical Device & Diagnostics

  • Correo de contacto:

    michael_rownicki@oxfordcorp.com

OXFORD OPPORTUNITY
Role / seniority

Client industry:Medical deviceSchedule:2 days per week
Position:Regulatory Affairs Staff SpecialistLocation:Remote (client is based in Kelberg, Germany)
Start date:ASAPLOA:6 months
On site/remote:RemoteLanguages:Ideally German speaking



PROJECT DESCRIPTION
Your role as Regulatory Affairs Staff Specialist (m/f/d) is to combine knowledge of
scientific, regulatory, and business issues to enable product development, manufacture,
and life cycle maintenance to ensure compliance with applicable regulatory
requirements and technical standards.
You have strong communication and influencing skills to ensure cross-functional teams
are engaged in the compliance process. You are detailed in your thinking and have
excellent organizational skills allowing you to identify, obtain and gather the required
product technical documentation to demonstrate regulatory compliance.
We are seeking an enthusiastic teammate, able to participate with ownership in a
complex and fast evolving environment. Experience with CE Marking products under the
Machinery, EMC, LVD, RED, RoHS directives or within machinery engineering is
desired. Strong knowledge in international standards and regulations including ISO
9001, ISO 13485 is preferred.
Your role will be challenging and diverse, giving you the opportunity to play a key part
in supporting the business to achieve our ambitious goals and new markets growth
plans.

SKILLS/ QUALIFICATIONS NEEDED
Duties and responsibilities

  • Prepare and maintain product technical files in accordance with applicable EU regulations
  • Manage international product registrations according to individual country specific requirements in sync with marketing team objectives
  • Support cross-functional product development teams as the regulatory representative in all phases of the product development for new products and for design changes
  • Formulate regulatory affairs processes and procedures relating to product compliance in collaboration with cross functional inputs
  • Monitor and assess changes in regulations and provide guidance to cross functional teams to determine their impact and achieve compliance
  • Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory action and to ensure compliance to international requirements
  • May attend to audits performed by internal and external authorities to represent


Skills and qualification

  • Sound knowledge of the regulatory framework pertaining to EU Machinery Directive and other EU directives related to CE marking (e.g. EMC, LVD, RED directives), and applicable standards
  • Knowledge of EU environmental standards (RoHS, REACH)
  • Experience in a design and manufacturing business of machines
  • Strong English and German communication skills
  • BSC or equivalent in engineering or scientific discipline
  • +3 years` experience in similar role preferred

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