25 days old

Regulatory Affairs MDR Specialist (1of7)

Kelly Services
Remote, MA
Kelly is currently recruiting for a Regulatory Affairs Specialist to support day-to-day regulatory activities of assigned projects for MDR compliance.

**Principle responsibilities**

1. Execute projects in accordance with the cadence.

2. Support communication strategy to NPD staff to maximize understanding of expected impact from the MDR program to NPI.

3. Collaborate with stakeholders to develop and maintain project plans.

4. Create, monitor and analyze project risks and identify mitigation strategies.

5. Be responsible for all project communications to all cross-functional project stakeholders and communications include; project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.

6. Report metrics of completion status to manager / Leadership Team.

7. Work with project team to identify and address critical path or roadblock issues.

8. Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.

9. Be the liaison with stakeholder managers as needed to ensure project goals are achieved.

10. Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.

11. To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable part.

12. Review and approval of documentation to support Technical Document to meet MDR requirements.

13. Participate in cross functional teams to discuss and revise documents to meet MDR requirements.


1. A minimum BA/BS Degree with at least 5 years of regulated medical device industry experience

2. Knowledge of orthopedic implants a plus

3. Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required

4. Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus

5. Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus

6. Familiarity with electronic submission preparation a plus

7. Excellent written and oral communication skills

8. Ability to handle multiple tasks and be detail oriented

**This position comes with enhanced benefits which include:**

+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)

+ Paid sick days and vacation days

*benefits to be received upon meeting eligibility requirements

**_Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume._**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-11-06 Expires: 2020-12-07

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Regulatory Affairs MDR Specialist (1of7)

Kelly Services
Remote, MA

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