Regulatory Expert

Posted 06 Nov 2018

Temecula, California - United States

Req Id 183863

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your role: Assist in all activities related to maintaining compliance with requirement of FDA 21 CFR 820, CMDR SOR 98-292, IVDD EN 9879/EC, ISO 13485:2016, IVDR, and all other applicable International Medical Device Regulations. This position should be able to independently handle various clinical study assignments in support of regulatory submissions to the FDA, Notified Bodies, or other regulatory authorities as required. • Research, prepare, and update technical files and content, 510(k) submissions, instructions for use, and other regulatory content, in consultation with the cross-functional project team, investigators, data management and FDA.• Provide Regulatory representation during audits.• Write domestic and international regulatory submissions, to include Design Dossiers for CE marking and technical files.• Perform surveillance and advocacy for relative regulations on a global basis • Maintain Regulatory Registrations and licenses.

Who you are:

  • BS Degree with 8+ years of experience; MS Degree with 3+ years of experience
  • Strong knowledge in FDA 21 CFR 820, CMDR SOR 98-292, IVDD EN 98/79/EC, ISO 13495:2003, International Medical Device Regulations
  • Knowledgeable in Electronic and Electrical Equipment regulations
  • Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
  • Strong Computer skills (MS Office products, word processing, spreadsheets, etc.)
  • Ability to multi-task. Strong prioritization and organizational skills
  • Strong problem solving skills. Knowledge of principles of clinical research study design
  • Strong knowledge of Good Clinical Practice (GCP) and Regulatory compliance guidelines and regulations for clinical trials
  • General experience in medical device manufacturing
  • Regulatory requirements / submissions, and worldwide experience in medical devices from the Regulatory and clinical perspectives
  • Strong motivator/communicator in a compact clinical team working with aggressive timelines.
  • Good communication/negotiation skills with clinical investigators and academic thought leaders highly professional demeanor

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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