Job Description

TalentSphere Staffing Solutions is partnered with a growing and cutting-edge life sciences company in the Greater Vancouver region focused on developing and commercializing products to transform health management. As a Global Director of Clinical Regulatory Affairs, you will play a pivotal role in ensuring their products gain necessary approvals in international markets, including the USA, Canada, Europe, Asia, and beyond.
You are a can-do, positive attitude supportive leader, who embraces a culture of growth and change and thrives in a rapidly changing environment. Work with dedicated scientific minds at the initial steps of a company scaling up. Make your mark and provide direction to their global strategy in this full-time, on-site role.

Responsibilities

We are seeking a highly skilled and experienced Global Director of Clinical Regulatory Affairs to develop and execute on our regulatory strategy for various products in various global markets. The ideal candidate will have a deep understanding of international regulatory requirements and will be responsible for developing and executing strategies to navigate the regulatory landscape and gain product approvals in key markets.

• Clinical & Regulatory Strategy Development
• Global Market Approvals
• Regulatory Compliance
• Regulatory Submissions and Intelligence
• Cross-functional Collaboration

Qualifications Required

• PhD in immunology or a related life sciences field with a minimum of 10+ years of experience in Clinical Regulatory Affairs within the IVD industry, or an equivalent combination of education and expertise.
• Proven track record of multiple product approvals in the US and global jurisdictions.
• Established network of contacts and relationships with regulatory bodies.
• Experience with early and late stage IVD development and validation and regulatory approval process.
• In-depth demonstration and knowledge of developing IVD regulatory strategy and other activities.
• Great familiarity with medical device and IVD standards and regulations.
• Hands-on experience preparing and accomplishing complex submissions to global regulatory agencies.
• Expert analytical and problem-solving abilities thriving in a rapidly evolving environment.
• Exceptional leadership skills, excellent communication and interpersonal skills.

Salary Range $95,000 - $135,000 commensurate with experience.

What\xe2\x80\x99s in it for you?

This is an opportunity to develop your career with a highly respected growing industry leader. A culture that places an emphasis on teamwork, inclusiveness and tenacious to see results in their work and health outcomes.

Only candidates legally entitled to work in Canada will be considered.

Benefits:

• Casual dress
• Proximity to SkyTrain and bike routes
• Free parking near by
• Company events
• Extended Healthcare
• Flexible schedule
• On-site gym

TSSHP
LI-TS1

(#16322647)

TalentSphere