Platform Principal Regulatory Affairs Specialist
Work Shift:
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
1. Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.
2. Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
3. Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.
4. Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.
5. Partners with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.
6. In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.
7. Supports and suggests continuous improvement of regulatory processes, procedures and policies.
8. Ensures compliance with relevant regulatory requirements.
9. Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.
10. Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.
11. Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood. Coordinates with Regional RA on the integration of new acquisitions.
12. Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.
13. Performs other duties and tasks as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. -- local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
MINIMUM QUALIFICATIONS
• Education and/or experience equivalent to Bachelor’s degree in a technical field such as in the biological, physical, engineering, material science, regulatory, legal or related disciplines.
• 15+ years of Regulatory Submissions experience in the medical device industry.
• Considered an expert with demonstrated knowledge, use, and/or application of applicable medical device regulations (Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls).
• Identify and frame concepts with a basic understanding of business impact.
COMPETENCIES
• Project management
• Written and Verbal Communication
• Attention to Detail
• Continuous Improvement
• Analytical Skills
• Strategic leadership
• Team development
• Results oriented
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
* 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
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
1. Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.
2. Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
3. Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.
4. Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.
5. Partners with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.
6. In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.
7. Supports and suggests continuous improvement of regulatory processes, procedures and policies.
8. Ensures compliance with relevant regulatory requirements.
9. Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.
10. Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.
11. Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood. Coordinates with Regional RA on the integration of new acquisitions.
12. Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.
13. Performs other duties and tasks as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. -- local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
MINIMUM QUALIFICATIONS
• Education and/or experience equivalent to Bachelor’s degree in a technical field such as in the biological, physical, engineering, material science, regulatory, legal or related disciplines.
• 15+ years of Regulatory Submissions experience in the medical device industry.
• Considered an expert with demonstrated knowledge, use, and/or application of applicable medical device regulations (Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls).
• Identify and frame concepts with a basic understanding of business impact.
COMPETENCIES
• Project management
• Written and Verbal Communication
• Attention to Detail
• Continuous Improvement
• Analytical Skills
• Strategic leadership
• Team development
• Results oriented
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
* 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
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.