- Project Planning
- Project Management
- Microsoft Powerpoint
Job ID: 2018-12116
Career Level: experienced
Location: Tempe,Arizona,United States
Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.
Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.
Summary of Position with General Responsibilities:
The Regulatory Affairs Specialist (RAS) demonstrates ability to create and communicate global regulatory requirements thoughout the product lifecycle working closely with a cross functional team. The RAS is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues. The RAS is responsible for ensuring compliance with the regulations and Bard Peripheral Vascular's processes and procedures. The RAS utilizes project planning skills to initiate, plan, execute, and manage regulatory projects and submissions. The RAS manages change and is flexible when providing solutions. The RAS demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency parners by building strong and effective working relationships.
Essential job Functions:
Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations.
Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals.
Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.
Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs.
Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and global regulations and standards. Ensures maintenance of the Regulatory Affairs files.
Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular’s notified body.
Works with the regulatory mangament team to ensure compliance with Corporate Regulatory.
Working knowledge of U.S., European and/or global regulations and standards covering medical devices.
Minimum of 2 years of RA related experience.
Additional Desirable Qualifications Skills and Knowledge:
Excellent communication (both verbal and written) skills.
Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
Demonstrated problem-solving and analytical skills.
Solid project management skills.
Experience working with others in a team environment.
Education and/or Experience:
Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
510(k) submission experience required. PMA submission experience a plus.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.