Cardinal Health Senior Regulatory Affairs Specialist in Mansfield, Massachusetts

SUMMARY OF POSITION :

Cardinal Health is seeking a Regulatory Affairs Specialist to support the Patient Care and Safety Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices which include support of 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 Care and Safety business.

SCOPE OF DUTIES/ACCOUNTABILITIES/JOB DESCRIPTION :

The 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:

  • Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), PMA, Technical Files, Design Dossiers
  • Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
  • Review design control documents including documents associated with design inputs and design outputs
  • Review product labeling for compliance with global labeling regulations
  • Review advertising and promotional literature for compliance with applicable regulations
  • Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies

MINIMUM REQUIREMENTS:

Education:

  • Bachelor’s Degree in a scientific discipline

Skills/Qualifications:

  • 4+ years Regulatory Affairs Experience or equivalent
  • Majority of Regulatory Affairs experience in Medical Device industry preferred

Competencies:

  • Proficiency in US and Europe medical device regulations
  • Strong organizational skills
  • Ability to manage multiple projects
  • Deadline conscious
  • Problem solving skills
  • Team oriented
  • Strong oral and written communication skills

Other skills:

  • Fluent in local language required

OTHER REQUIREMENTS :

  • Travel time required, up to 5%

WORKING CONDITIONS :

  • General office environment

PHYSICAL JOB REQUIREMENTS:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EEO STATEMENT:

It is the policy of Cardinal to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cardinal will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http :// www.uscis.gov/e-verify/employees

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.