Senior Regulatory Affairs Specialist

Cardinal Health • Mansfield, MA 02048

Posted 1 month ago

Job Description

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.


SUMMARY OF POSITION:


The Senior Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to:

  • Under direction, support new product development/modifications projects to establish and integrate regulatory submissions strategy into project activities.
  • Under direction, prepare submissions (i.e. 510(k), CE marking applications, technical documentation, etc.) to obtain US regulatory clearance, European regulatory approvals, and maintain existing regulatory approvals through Letter to File, renewals, change notifications, etc.
  • In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist with STED Preparation for medical devices in countries in which products are to be registered.
  • Interpreted and/or evaluate proposed registration requirements for medical device and advice on impact of such regulations to the company.
  • Review device labeling and marketing literature for compliance with global labeling regulations and product filings.
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
  • Evaluate, develop and implement business process improvements.

ESSENTIAL FUNCTIONS:


  • Interface with project teams
  • Create and maintain regulatory filings (e.g. product submissions, device listings)
  • Review change control documents and ascertain regulatory impact
  • Monitor regulatory landscape

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:


  • Effective project management skills
  • Ability to create cross-functional partnerships
  • Ability to apply judgment within defined parameters
  • Ability to maintain multiple projects
  • Deadline conscious
  • Effective negotiation skills
  • Ability to work collaboratively in a team environment
  • Effective oral and written communication skills
  • Effective problem-solving skills

MINIMUM REQUIREMENTS:


Education:

  • Bachelors in related field, or equivalent work experience, preferred

Experience:

  • 2+ years Regulatory Affairs experience or equivalent required
  • Majority of Regulatory Affairs experience in Medical Device industry preferred

Language:

  • Fluent in local language required

ORGANIZATIONAL RELATIONSHIPS/SCOPE:


The Senior Specialist of Regulatory Affairs will report into the Manager Regulatory Affairs for Cardinal Healths Patient Recovery business. Interaction with cross-functional representatives at the Project Team and Manager Levels will be frequent.



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.
 

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