ESSENTIAL FUNCTIONS PERFORMED

Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.

Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D;, Operations, Clinical Affairs and Quality Assurance.

Ensures all regulatory activities for assigned platform and operations projects comply with evolving integral regulatory requirements.

Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.

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.

In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.

Supports and suggests continuous improvement of regulatory processes, procedures and policies.

Ensures compliance with relevant regulatory requirements.

Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.

Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.

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.

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📌 Senior Platform Regulatory Specialist (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte