Fresenius Medical Center Senior Regulatory Affairs Associate - Devices in Waltham, Massachusetts
PURPOSE AND SCOPE:
Responsible for the preparation of regulatory submissions required to market new or modified medical devices in the domestic and international clinical market. Develops and maintains procedures and systems to ensure the product development process addresses all regulatory requirements and business objectives. May act as FDA liaison for assigned projects. Reviews and advises on manufacturing and control changes for marketed products, labels and clinical materials.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Evaluate and assess regulatory impact of proposed product changes.
Understand and interpret U.S. and international medical device regulatory requirements; provide guidance on requirements to assigned product development teams.
Develop strategies for submissions to FDA and other regulatory agencies. Provide regulatory risk assessments and options to product development teams.
Responsible for preparing FDA submissions necessary for new product approval/clearance and product continuance:
Pre-market notifications 510(k)s
Pre-market Approval Applications (PMAs) and supplements
Investigational Device Exemptions (IDE) submissions
Prepare Regulatory Assessments and Notes to File for assigned projects.
Prepare and maintain CE Dossiers and Canadian licenses as assigned.
Critically review all documents for regulatory submissions, including product labeling and promotional and advertising material.
Prepare domestic and international regulatory strategies for the introduction of new products.
Coordinate the preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests.
Develop and maintain regulatory procedures and policies to ensure ongoing compliance of existing and new products.
Responsible for compiling and submitting other applicable reports as necessary.
May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
May escalate issues to supervisor/manager for resolution, as deemed necessary.
Support product development teams.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Assist with various projects as assigned by a direct supervisor.
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.
Submission work can involve lifting multiple volumes each weighing approx. 5 pounds. There is some overhead lifting when removing such volumes from an upper file drawer.
10 – 15% domestic and international travel as required.
Bachelor’s Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
Strong understanding of medical device guidelines and regulations.
Demonstrated working knowledge of scientific principles.
A self-starter with the ability to work independently and as part of a small team.
Very detail-oriented, well organized, and driven to meet deadlines and program goals.
Strong interpersonal, verbal and written communication skills, including the ability to make effective and persuasive presentations.
Good computer skills with knowledge of Microsoft Office.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity