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
EXPERIENCE AND REQUIRED SKILLS:
6 – 8 years’ related experience.
3+ years’ supervisory or project/program management experience preferred. Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.
Prior 510(k) experience required.
Experience with international regulations preferred.
Demonstrated working knowledge of scientific principles.
Demonstrated ability to work effectively in a highly charged, fluid environment.
Demonstrated ability to independently manage multiple projects.
A self-starter with the ability to work as a Project Leader managing projects and allocation of resources to those projects.
Very detail-oriented, well-organized, and driven to meet deadlines and program goals.
Strong verbal and written communication skills, including the ability to make effective and persuasive presentations.
Good computer skills with knowledge of Microsoft Office.
Supports FMCNA's new medical device and marketed product development. Oversees preparation of US, Canada, Mexico and other international regulatory submissions for new products, investigates and implements changes to existing products in compliance with applicable international and US federal laws. Provides leadership to a staff of regulatory professionals engaged in preparation of regulatory submissions in support of new product development and changes to existing products. Maintains compliance with US and appropriate international regulatory requirements.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Develops product regulatory approval strategies in collaboration with senior department management. Independently oversee implementation of project plans for assigned products/product lines.
Manages assigned Regulatory Affairs devices personnel. Hire, train and develop staff members. Provide timely and appropriate performance feedback.
Provides regulatory guidance to product development teams. Advise teams and management on worldwide regulatory requirements.
Ensures compliance with US (FDA), Canadian, Mexican and other regulatory submission requirements for medical device registrations.
Manages timelines and priorities on all submissions.
Ensures that submissions are processed in a timely fashion.
Oversees preparation of regulatory assessments for proposed product design changes.
Interacts with FDA or other regulatory agencies regarding regulatory strategies for assigned products/product lines.
Prepare SOPs to ensure compliance with all applicable US and international regulatory requirements.
Provide technical guidance.
Assist with various projects as assigned.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
10 – 15% domestic and international travel required.
May be responsible for the direct supervision of various levels of Regulatory Affairs staff.
Fresenius Medical Care North America is the premier health care company focused on delivering the highest quality care to people with renal and other chronic conditions.Worldwide, more than 2.5 million patients with this disease regularly undergo dialysis therapy, a vital blood cleansing procedure that substitutes the function of the kidney in the case of kidney failure.Through our industry-leadin...g network of more than 2,200 dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as the country’s largest practice of hospitalist and post-acute providers, Fresenius Medical Care provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s only vertically integrated renal company, we also offer specialty pharmacy and laboratory services, as well as manufacturing and distributing the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals.Our integrated approach helps to not only improve patients' health outcomes, but also reduce the total cost of care.Around the world, we care for more than 290,000 renal patients in our global network of more than 3,400 dialysis clinics. At the same time, we operate more than 40 production sites on all continents, to provide dialysis products such as dialysis machines, dialyzers and related disposables.Our strategy is geared toward sustainable growth. We aim to continuously improve the quality of life of patients with kidney disease by offering innovative products and treatment concepts of the highest quality.Fresenius Medical Care’s corporate headquarters is in Bad Homburg, Germany. Our North American headquarters is in Waltham, Massachusetts and our Asian-Pacific headquarters is located in Hong Kong.