Fresenius Medical Care North America (FMCNA) is the premier health care company focused on providing high quality care to people with renal and other chronic conditions. FMCNA designs, manufactures and distributes a comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals.
Rewarding. Innovative. Challenging. That’s what defines a Regulatory Affairs career at Fresenius. From inception to final approval, we’ll rely on you to successfully guide our dialysis products through their entire life cycle providing invaluable expertise every step of the way. Through it all, you’ll take pride in knowing you’re making a profound difference in the lives of patients affected by kidney disease.
The Regulatory Affairs organization at FMCNA is responsible for all FDA submissions related to both our Medical Devices and Pharma products. The Medical Devices organization where this role sits is responsible for various Disposables including Dialyzers, Bloodlines and Concentrates. Your familiarity with Class II or Class III Medical Devices, your exemplary writing skills, your attention to detail and your ability to be both a humble and knowledgeable team member are some of the keys to your success at FMCNA. Our refined submission processes, our knowledgeable, industry-savvy team and extremely strong relationship with FDA, are just a few of the great reasons for making FMCNA the next destination for your career!
We look for Regulatory Affairs experience with as many of the following as possible:
Biocompatibility Standards and Material Qualification
Disposable Medical Devices
"Combination" Medical Device/Pharma/Disposables Products
Software Driven Medical Devices
Class II/Class III Medical Devices
Our Regulatory team participates in all FMCNA new product development teams. In some companies, Regulatory Affairs is just another support organization; submissions “pass through” those groups with little more expected beyond monitoring the submission process. FMCNA is different. As a result, we offer a great opportunity to really broaden your skills. At FMCNA, the Regulatory Affairs group truly owns the FDA relationship and is totally responsible for “leading, guiding, project managing” submissions, as well as “interacting” with all parts of the FMCNA product development team.
What will you do at Fresenius?
You will prepare FDA submissions for new products and product changes to ensure timely clearances and market release (e.g. 510(k)s, Notes to File, Pre-Submissions, IDEs, and Additional Information Responses etc.).
You will team with and may mentor/supervise other Regulatory Affairs specialists, and work with cross-functional team members from Engineering, R&D, Clinical/Medical, Biocompatibility, Marketing, Quality, Human Factors and other technical experts to resolve potential regulatory issues and questions from regulatory agencies.
You will provide support for currently-marketed products, including reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.
You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
You will be expected to exercise solid judgment in selecting methods, techniques and evaluation criteria for obtaining results.
You will add to your knowledge base by networking with key contacts outside your own area of expertise.
No one is perfect, but ideally we look for as many of the following Technical and Professional Competencies as possible!
- Knowledge of the medical device Regulatory Affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, etc.
- Knowledge of US laws, regulations, and guidances that affect assigned devices
- Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate to product development and labeling regulatory activities for assigned devices
- Ability to influence and partner with cross-functional teams
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
- Demonstrated ability in analytical reasoning and critical thinking skills
- Strong capability to contribute and lead in a team environment
- Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
- Excellent communication skills; both oral and written
- Strong interpersonal skills with the ability to influence others in a positive and effective manner through technical excellence and mutual respect
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Capacity to react quickly and decisively in unexpected, fluid situations
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
- Focused ability to influence operational excellence and performance metrics
- A risk averse nature when needed, with the ability to identify potential solutions to complex problems