ESSENTIAL JOB FUNCTIONS

1. Identifies functions and business practices requiring compliance activities and assists in coordinating with other organizational functions / departments on the elements of the compliance program to ensure that the whole staff is knowledgeable of and comply with applicable federal, country and industry standards.
2. Complies with federal, country and regulatory agencies by studying existing and new requirements; enforcing adherence to requirements; advising management on needed actions.
3. Provides administrative support by implementing systems, procedures, and policies; completing projects in support of compliance team.
4. Answers questions both internally and externally and responds to all compliance requests and spreadsheets.
5. Reviews all new products, systems or processes to ensure compliance.
6. Identifying and assessing areas of significant business risk and works with Quality and Engineering to mitigate these risks.
7. Define, develop and maintain the compliance documentation structure and files.  Work with Marketing Communication to maintain accurate compliance documentation is posted on the company website.
8. Provide assistance and support with regulatory elements for the technical file and tollgates.
9. Supports and provides regulatory adherence during internal / external audits
10. Increases compliance knowledge by participating in educational opportunities; reading publications, training sessions, webinars.
11. All other duties as assigned

QUALIFICATIONS/SPECIAL SKILLS

The compliance coordinator is required to have an Associate’s degree and 2 -3 years’ experience in the medical device compliance field dealing with regulatory requirements. Should be confident, professional and self-motivated with a keen interest in ethical, legal and regulatory requirements. Requires both computer and writing skills, with the ability to work on their own initiative and as part of a team.