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- Mansfield, MA
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Senior Regulatory Affairs Specialist
Cardinal Health • Mansfield, MA
Posted 30 days ago
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SUMMARY OF POSITION:
The Regulatory Affairs (RA) Specialist will support the Patient Recovery team. The RA Specialist will provide regulatory support on a range of medical devices and activities which include change development projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient Recovery business.
- Support the preparation, submission, and maintenance of global product registrations with a focus on U.S. 51 O(k)s, EU Technical Files, and EU Design Dossiers
- Provide regulatory guidance to cross-functional teams tasked with change development projects and ascertain global regulatory impact
- Provide regulatory guidance to cross-functional teams tasked with maintenance of business projects and ascertain global regulatory impact
- Collaborate with internal departments to obtain and understand registration requirements
- Review design control documents which include those associated with design inputs and design outputs
- Review product labeling for compliance with global labeling regulations
- Review marketing literature for compliance with regulations governing advertising and promotion
- Improve regulatory intelligence by attending regulatory seminars and meetings
- Maintain current regulatory databases and produce various reports as needed
- Maintain and provide regulatory information in support of queries from customers, customs, bids, tenders, post-market surveillance related queries, government queries, etc.
- Basic knowledge of US and Europe medical device regulations
- Create and maintain regulatory filings ( e.g. product submissions)
- Review change control documents and ascertain regulatory impact
- Recommend strategies based on current local registration requirements and applicable industry standards
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Effective project management skills
- Ability to create cross-functional partnerships
- Ability to work collaboratively in a team environment
- Effective oral and written communication skills
- Effective problem-solving skills
- Strong organizational skills
- Ability to manage multiple projects
- Deadline conscious
What Reg Affairs Manufacturing FDA contributes to Cardinal Health
Regulatory Affairs Manufacturing (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
- Bachelors in related field, or equivalent work experience, preferred
- 2+ years experience in related field, preferred
What is expected of you and others at this level
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
The Regulatory Affairs Specialist will report into the Regulatory Affairs Manager for Patient Recovery. Interaction with cross-functional representatives at the Project Team and Manager levels will be frequent. Interaction with management at the Director level will be moderate.
Travel Time required, up to 5%
METHOD OF VERIFYING COMPETENCE:
Competency will be evaluated through mechanisms such as the annual review process, feedback from internal customers, submission metrics, internal/external audits of the RA function, etc.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.