Platform Principal Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Utah.

📋 Description

• Works collaboratively with key stakeholders to ensure that regulatory objectives are aligned with the strategic priorities of the organization.

• Builds and sustains strong strategic partnerships with project team members, including those in Marketing, R&D, Operations, Clinical Affairs, and Quality Assurance.

• Guarantees that all regulatory activities for assigned platform and operations projects adhere to evolving global regulatory standards.

• Keeps product knowledge current within the team and ensures that essential data is collected and organized to support global submissions.

• Collaborates with the Regional RA team to develop, align, and implement Regulatory strategies for platform and operations projects and changes, maintaining high standards of accuracy, timeliness, compliance, and excellence in regulatory strategy.

• In partnership with Regional RA, effectively represents Merit in interactions with Regulatory authorities, enhancing Merit's reputation and credibility.

• Aids in and proposes ongoing improvements to regulatory processes, procedures, and policies.

• Ensures adherence to relevant regulatory requirements.

• Keeps project teams updated on new and forthcoming regulatory changes and evolving interpretations, along with their potential impacts.

• Ensures the accurate and timely maintenance of regulatory data with a high level of compliance.

• Assists Regulatory Affairs in due diligence efforts to ensure that regulatory risks and integration requirements are clearly articulated and understood, collaborating with Regional RA on the integration of new acquisitions.

• Supports and, when necessary, represents Regulatory Affairs during audits and inspections, leading to successful outcomes.

• Performs additional duties and tasks as required.

⛳️ Requirements

• Education and/or experience equivalent to a Bachelor’s degree in a technical discipline such as biological, physical, engineering, material science, regulatory, legal, or related fields.

• Over 15 years of experience in Regulatory Submissions within the medical device sector.

• Recognized as an expert with proven knowledge, application, and understanding of relevant medical device regulations (Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls).

• Ability to identify and frame concepts while possessing a fundamental understanding of business impacts.

🏝️ Benefits

• 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