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 more than 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.
The Regulatory Affairs Subject Matter Expert will ensure that departmental objectives are implemented in line with the overall site, department, and corporate goals and objectives. You will be dedicated to ensuring continual compliance to all applicable regulations. Manage assigned regulatory tasks related to health authority notifications / submissions / registrations regarding new products, changes to products or sale of products in new territories. Ensure site regulatory strategy aligns with overall corporate regulatory strategy, goals and objectives. Carry out regulatory review of documents and changes. Carry out impact assessments where required. Review customer complaints for incidents requiring vigilance reporting or regulatory involvement. as assigned through the Quality System as appropriate.
In this role you will also assemble and maintain technical files, device master records and other regulatory documentation to ensure current, and changes recorded. Maintain library/database of standards and regulation. Review of updated standards and regulations, carry out documented review, ensuring any necessary updates are made and disseminating information throughout the site. Manage regulatory review for new product introductions, CAPA investigations, printed materials, validations and general projects. Support preparation of and participate in any customer audits which require regulatory input. Support preparation for and participate in audits by regulatory bodies. Carry out regulatory gap analysis and audits related to changing or new regulations. Respond to customer (internal & external) regulatory requests or enquiries. Support any recall or notification actions & carry out regulatory vigilance reporting as required. Act as liaison between site and notified body or other regulatory authorities.
Who you are:
- Bachelors’ Degree in biology, biochemistry, or similar life science discipline
- 3+ years of work experience in a Regulatory Affairs environment
- 3+ years of experience working with FDA medical device regulations, particularly for Class I medical devices/IVDs; Research Use Only (RUO), Analyte Specific Reagents (ASRs), and labeling requirements for these product types
- 3+years of experience working with IVDD, transitioning to IVDR to be able to provide regulatory guidance
- 3+ years of experience working with EU medical device regulations
- 3+ years of experience working with technical files
- 3+ years of experience working with requirements in U.S., E.U.
- Familiarity with global regulations, Asia, Latin America, Eastern Europe, Africa, Middle East,
- Familiarity with global requirements for IVD product registrations
- Experience managing regulatory mitigation projects
- Experience writing regulatory assessments and risk assessments related to regulatory guidance and advice to the site
- Highly cooperative and collaborative
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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.