Regulatory Transformation Specialist

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Regulatory Transformation Specialist supports enterprise regulatory transformation initiatives by providing operational analytical and documentation support across Regulatory Intelligence Policy and Advocacy EU MDR compliance activities process harmonization and remediation efforts.

This role operates as an individual contributor and works under the direction of senior regulatory leaders to support the execution of global regulatory transformation initiatives. The Specialist assists in monitoring evolving regulatory requirements maintaining regulatory intelligence tools and trackers supporting process standardization efforts and contributing to audit readiness and remediation activities. The role requires strong organizational skills attention to detail and the ability to work effectively across cross-functional teams within a regulated medical device or life sciences environment. Further the Regulatory Transformation Specialist is expected to apply foundational regulatory knowledge follow established procedures and escalate issues appropriately while contributing to continuous improvement initiatives that enhance regulatory compliance scalability and operational effectiveness.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily with minimal oversight.

• Support enterprise regulatory transformation initiatives including EU MDR compliance activities US remediation efforts and strategic regulatory programs.

• Monitor regulatory updates standards and guidance; maintain regulatory intelligence databases trackers and summary reports.

• Assist with competitor analyses animal tissue monitoring activities and documentation of regulatory impact assessments.

• Support policy and advocacy activities including preparation of policy summaries tracking regulatory consultations and coordination of industry working group participation. Assist in documenting maintaining and harmonizing regulatory processes SOPs templates and process maps.

• Support global labeling and label harmonization activities including end-to-end labeling workflows and electronic Instructions for Use (eIFU) documentation.

• Track CAPA and nonconformance activities maintain remediation documentation and support inspection and audit readiness activities.

• Assist with regulatory documentation and compliance tracking for mergers acquisitions and integration activities.

• Support Compliance Master Plans remediation initiatives and continuous improvement projects within Regulatory Affairs. Support the development and maintenance of regulatory procedures and documentation that enable compliant device life cycle management across development registration and postmarket phases.

• Maintain awareness of regulatory pathways applicable to medical devices (e.g. premarket postmarket and change notifications) and escalate issues or risks as appropriate.

• Serve as an active member of the broader Regulatory Transformation and Operations group; participate in crosstraining and support activities as assigned to ensure business continuity operational flexibility and timely execution of regulatory priorities.

• This job description is not intended to be allinclusive; employees are expected to perform other duties as assigned that are relevant to departmental and business needs.

The requirements listed below are representative of the knowledge skill and/or ability required for this position.

• Bachelors Masters or Doctorate/PhD degree in Science Engineering Regulatory Affairs or other technically related field.

• Minimum of 2-4 years related experience with increasing responsibility in an FDA regulated industry such as Medical Devices Biotech or Pharma. Certification in Regulatory Affairs Professional Society (RAC) encouraged. Education or certification in lieu of relevant experience accepted when the requirements below are met:

  • Regulatory Affairs Certification (RAC) can count towards 1 year of specific RA experience.

  • Masters degree can count towards 2 years of relevant (non-RA) experience.

  • Terminal degree (Doctorate or PhD in Business Science or related discipline) can count towards 4 years of relevant (non-RA) experience.

• Foundational knowledge of regulatory requirements applicable to medical devices and/or life sciences.

• Familiarity with EU MDR FDA regulations ISO standards and quality system concepts preferred.

• Strong organizational skills with the ability to manage multiple tasks trackers and documentation deliverables simultaneously.

• High attention to detail and accuracy in documentation and data maintenance.

• Ability to follow established procedures templates and governance models.

• Effective written and verbal communication skills.

• Ability to work collaboratively with cross-functional stakeholders.

• Proficiency with common business systems and tools (e.g. document management systems spreadsheets databases).

• Demonstrated ability to learn new regulatory concepts tools and processes.

Salary Pay Range:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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