Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

West Lothian

Permanent

Role Profile

Reporting to the Head of Regulatory and Clinical Affairs or Regulatory Affairs Manager, the Senior Regulatory Affairs Associate will be responsible for the preparation and maintenance of global regulatory submissions in accordance with the business strategy and objectives. The successful candidate will assist in the assessment of the regulatory impact of product and process changes and provide input to the planning and roll-out of changes to registered products. The role holder will proactively identify and interpret new implementing acts, guidance, and standards.

Key aspects of the role

• Submission and maintenance of global regulatory filings. Supports roll out of changes. Capable of proposing solutions to regulatory challenges. Ensures that all regulatory requirements are met for the markets concerned.
• Preparation, review and maintenance of technical documentation such as STED documentation and product labelling
• Prepares responses to questions raised during regulatory submission process and/or audits to ensure approvals are obtained in line with business needs
• Proactively keeps abreast of new regulatory requirements and standards, evaluates changes and provides input to other project stakeholders.
• Supports product lifecycle by providing RA input to processes such as Post Market Surveillance, Change Control and Risk Management.

Applicant requirements

• Honors degree in science or other relevant subject area or equivalent industry experience.
• possess relevant post-academic experience within medical devices, IVD, or pharmaceuticals
• a solid understanding of EU and other international regulatory requirements.
• excellent written and verbal communication skills.
• organised and able to work to tight deadlines with superior attention to detail
• experience of interpreting regulatory documents, and able to grasp and convey complex technical information.

Desirable

• Knowledge of filing EU regulatory submissions and working with Notified Bodies or other international authorities.