Senior Regulatory Affairs Specialist

Beschreibung

Senior RA Specialist

Structure: Hybrid

Duration: 7 months

Responsibilities:

* Oversees preparation of documentation for regulatory submission dossiers, ensuring high quality.
* Collaborates with engineers and experts to devise regulatory strategies and address inquiries from regulatory agencies.
* Represents the company in engagements with regulatory bodies, integrating their feedback into regulatory strategies.
* Works with global regulatory partners to support strategy for product changes.
* Leads regulatory filings for submissions, license renewal, and registrations.
* Supports manufacturing strategy through robust change control for global approval of product and process changes.
* Stays updated on regulatory procedures and advocates for industry changes.
* Influences clinical evidence strategy for labeling and compliance.
* Assists in regulatory compliance activities, including site registration and audits.

Qualifications:

* Bachelor's or Master's degree in Science or Engineering, preferably with Regulatory Affairs qualification.
* Experience in Medical Devices or Pharmaceuticals regulatory affairs.
* Expertise in managing large projects or processes.
* Relationship builder with strong technical knowledge and critical thinking skills.
* Effective communicator, fluent in English, with strong organizational abilities.

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.