Senior Regulatory Affairs Specialist

pulmonx; Canada; Hybrid; USD 105,000 - 145,000; Full time

Job summary

An innovative company is seeking a Senior Regulatory Affairs Specialist to oversee regulatory compliance for medical devices in both US and international markets. This role is vital in ensuring that products meet regulatory standards and involves developing international strategies for market entry. You will collaborate with various teams to align on regulatory matters and prepare necessary documentation for regulatory authorities. If you have a strong background in regulatory affairs, particularly with Class II or III devices, and possess excellent communication skills, this is an exciting opportunity to make a significant impact in a forward-thinking organization.

Qualifications

• 3-5 years of experience in regulatory affairs for Class II or III medical devices.
• Extensive knowledge of medical device regulations and standards.

Responsibilities

• Manage regulatory activities for medical devices in US and international markets.
• Collaborate with cross-functional teams on regulatory matters.

Skills

Regulatory Affairs

Communication Skills

Interpersonal Skills

Technical Report Writing

Education

Bachelor's degree in Life Science

Tools

ISO 13485

ISO 14971

IEC 62304

Job description

This role is ideally hybrid with some work onsite, but we will consider remote with some travel to the Redwood City office for the right person.

Position Overview

As The Sr Regulatory Affairs Specialist at Pulmonx, you will support all regulatory aspects of devices marketed and sold in US and OUS. Your expertise will be crucial in ensuring that all products meet regulatory requirements and in assisting with the development of international regulatory strategies.

Responsibilities and Capabilities :

• Manage all regulatory activities related to the registration and compliance of medical devices in US and rest of the world.
• Ensure that all products comply with relevant regulations and standards throughout the product lifecycle. Develop and implement international regulatory strategies to facilitate market entry and product approvals.
• Collaborate cross-functionally with teams in Commercial, Marketing, Quality Assurance, and Legal to ensure alignment on regulatory matters. Monitor and analyze changes in international regulations and assess their impact on existing and future products.
• Prepare and submit regulatory documentation to regulatory authorities in target markets.
• Lead and participate in meetings with regulatory authorities, as needed, to advocate for Pulmonx products and clarify regulatory positions.
• Maintain accurate records and documentation of regulatory submissions and communications with regulatory bodies. Stay current with industry trends and best practices in international regulatory affairs.
• Excellent interpersonal skills, focused, target driven with a positive, can-do attitude.
• Other duties as assigned.

Requirements :

• Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices. Bachelor’s degree in a Life Science is required.
• Experience authoring technical reports, business correspondence, and standard operating procedures.
• Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences.
• Extensive knowledge of a broad set of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304).

Compensation : $105,000 - $145,000 depending on experience

Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.