Regulatory Affairs Manager 5/18/2017
JOB DESCRIPTIONAPPLY A career with us is an ongoing journey of discovery: our 50,000 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.
Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Specific responsibilities for this position include:
* Manage and organize the Requlatory Affairs Department ensuring that departmental objectives are implemented in line with the overall Quality / Corporate goals.
* Ensure continual compliance to all applicable regulations.
* Manage regulatory notifications / submissions / registrations in regards to new products, changes to products or sale of products in new territories.
* Ensure site global 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.
* 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 reviewe 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 of and participate in audits by regulatory bodies.
* Carry out regulatory gap analysis and audits.
* 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:
* BS in technical degree or health science
* 10 years of Regulatory Affairs experience
* FDA IVD 510(k) submissions
* European Directives 98/79/EC or 93/42/EEC
* Regulatory audit experience FDA, European competent authorities, notified bodies.
* New product design and development
* Proficient in MS Office Software (Word, Excel, PowerPoint).
* Technical & report writing
* Project management
* Ability to work both in a team situation and individually with minimal supervision.
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.
MilliporeSigma is a division of Merck KGaA, Darmstadt Germany.