PURPOSE AND SCOPE:
Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Has broad expertise or unique knowledge; uses skills to contribute to the development of company objectives and principles, and achieve goals in creative and effective ways.
- Responsible for day-to-day oversight and management of assigned projects. Serves as primary regulatory resource for change to and prioritization of projects, resource assignment and efficient management of the development and change processes.
- Understands and interprets U.S. and international medical device regulatory requirements; provides guidance on requirements to product development teams.
- Develops strategies for submissions to FDA and other regulatory agencies. Provides regulatory risk assessments and options to product development teams and management.
- Assists in short and long-term schedule planning for the product development team.
- Responsible for preparing FDA submissions necessary for new product approvals/clearances which include Premarket norifictoins-510(k)s, Premarket Approval Applications (PMAs) and supplements, Investigational Device Exemptions (IDEs) submissions.
- Responsible for the preparation of Regulatory Assessment and Notes to File for assigned projects.
- Coordinates preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests.
- Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports.
- Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products.
- Assists with regulatory agency interactions.
- May provide leadership and direction to assigned resources. Provides timely and appropriate performance feedback.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises judgment in methods, techniques and evaluation criteria for obtaining results.
- Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others.
- Creates formal networks involving coordination among groups.
- Mentors other staff as applicable.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by 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.
- 10 – 15% domestic and international travel as required.
Bachelor’s Degree required; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 12 years of related experience; or a Master’s degree with 8 years of experience.
- Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments.
- Prior 510(k) experience required.
- Experience with international regulations preferred.
- Previous supervisory experience a plus.
- Demonstrated working knowledge of scientific principles.
- Demonstrated ability to work effectively in a highly charged, fluid environment.
- Demonstrated ability to independently manage multiple projects.
- As self-starter with the ability to work independently and as a Project Leader who will manage projects and and allocation of resources to those project.
- 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.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
You do not have any recently viewed jobs
You do not have any saved jobs