Senior Regulatory Affairs Specialist - Remote / Telecommute

Cynet systems Inc; Remote; GBP 100,000 - 125,000; Full time

Job summary

A regulatory compliance firm in the United Kingdom seeks a professional to develop regulatory strategies and provide guidance on registration requirements. The ideal candidate has a Bachelor's degree in a scientific discipline and 5-7 years of experience. Responsibilities include assessing regulatory impacts, managing change requests, and collaborating with teams to ensure compliance with regulations relevant to medical devices.

Qualifications

• 5-7 years of relevant experience.
• Coursework or training in regulatory matters is required.

Responsibilities

• Assess and develop regulatory strategy.
• Approve change requests and notifications.
• Guide teams on registration requirements.

Skills

Microsoft Office Suite expertise

Good communication skills

Problem-solving skills

Analytical thinking

Knowledge of global regulations

Attention to detail

Ability to manage priorities

Team collaboration

Education

Bachelor's Degree in scientific discipline

Job description

Pay Range: $60/hr - $64/hr

Responsibilities

• Participate in assessing and collating regulatory impact and developing regulatory strategy.
• Collaborate and approve change requests/change notifications.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and labeling content.
• Other incidental duties assigned by Leadership.

Additional Skills

• Coursework, seminars, and/or other formal government and/or trade association training required.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
• Good written and verbal communication skills and interpersonal relationship skills.
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast paced environment.
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
• Ability to build productive internal/external working relationships.

Education and Experience

• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry).
• 5-7 years of experience required.