Regulatory Affairs Expert with Medical Device Knowledge
hace 2 meses
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Merit Medical Systems Inc.
As a key member of our regulatory affairs team, you will be responsible for assisting in determining global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.
The ideal candidate will have a strong understanding of Mexico and CCA regulations, as well as experience with the Medical Devices Directive (93/42/EEC, as amended) and ISO 13485 Quality System Standards.
In this role, you will participate on various teams to define regulatory requirements of international submissions, Technical Files or regulatory rationales.
You will also identify guidance documents, international standards, Consensus Standards and assist teams with their interpretation.
Additionally, you will prepare regulatory submissions to the COFEPRIS and other CCA Ministries of Health, interact with various levels of management, external agencies and companies, and assist with analysis and making recommendations regarding complaints received by Merit Medical.
Key Responsibilities:
- Assist with determining global regulatory pathways for various projects
- Participate on various teams to define regulatory requirements of international submissions
- Prepare regulatory submissions to the COFEPRIS and other CCA Ministries of Health
- Interact with various levels of management, external agencies and companies
- Assist with analysis and making recommendations regarding complaints received by Merit Medical
Requirements:
- Education and/or experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience
- Knowledge of Mexico and CCA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards
- Supervisory skills are preferred
- Self-motivated, self-directing, strong attention to detail and excellent time management skills
- Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others
Salary Information:
The estimated salary for this position is $60,000-$80,000 per year, depending on experience and qualifications.
Benefits:
- Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
About Us:
Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
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