Senior Platform Regulatory Specialist

Merit Medical; Tijuana; On-site; MXN 600,000 - 1,100,000; Full time

Job summary

Merit Medical in Mexico (Tijuana) seeks an experienced Regulatory Affairs professional to align regulatory goals with the company’s strategic priorities. You will collaborate with Marketing, R&D, Operations and Quality Assurance to ensure global submissions meet evolving requirements.

The role demands strong knowledge of medical device regulations and hands-on experience with health authorities such as FDA, Notified Bodies and Health Canada; RAC certification is preferred.

Qualifications

• 8 years of progressive Regulatory Affairs experience in the medical device industry.
• Advanced English level.
• Prior experience in medical industry.
• Prior experience with health authorities and regulatory agencies (e.g., U.S. FDA, European Notified Bodies, Health Canada).
• Knowledge of global medical device regulations and Quality System Standards (ISO 13485, etc.).
• RAC certification strongly preferred.

Responsibilities

• Collaborates with key stakeholders to align regulatory goals with business priorities.
• Develops and maintains strategic partnerships with Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.
• Ensures activities comply with evolving global regulatory requirements for assigned platforms and operations projects.
• Maintains product knowledge and supports global submissions with organized data.
• Partners with Regional RA to develop, align and execute regulatory strategies for projects and changes.
• Represents Merit in interactions with regulatory authorities to strengthen credibility.
• Supports and suggests continuous improvement of regulatory processes, procedures and policies.
• Ensures regulatory data is accurate and up-to-date; informs teams of regulatory changes.

Skills

Advanced English

Regulatory knowledge

Attention to detail

Education

Bachelor’s degree in life sciences, engineering, regulatory affairs or related discipline

Tools

Regulatory software

Job description

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.

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

• Bachelor’s degree in life sciences, engineering, regulatory affairs or a related discipline.
• 8 years of progressive Regulatory Affairs experience in the medical device industry.
• Advanced English level
• Prior experience in medical industry
• Prior experience with health authorities and regulatory agencies such as U.S. FDA, European Notified Bodies, and Health Canada.
• Demonstrated general knowledge of global medical device regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls, reviewing and approving project plans, qualification protocols/reports. Modern computer skills.
• Relevant regulatory certifications (e.g., RAC) strongly preferred.

COMPETENCIES

• Project management
• Written and Verbal Communication
• Attention to Detail
• Continuous Improvement
• Analytical Skills
• Strategic leadership
• Team development
• Results oriented
• Integrity
• Organization

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.