Lead Regulatory Affairs Expert
2 weeks ago
Are you equipped with the necessary qualifications and expertise for this role? Read on to find out more.
This device presents a significant clinical advantage over existing treatment options, ensuring that its availability serves the best interests of patients.
Position Overview
The Senior Regulatory Affairs Specialist will play a pivotal role in supporting and facilitating essential regulatory affairs functions within the organization, alongside overseeing advertising, promotional, and standards review processes.
This role is crucial in guaranteeing that all marketing materials associated with the medical devices marketed and sold adhere to FDA regulations, international standards, and company policies.
Key Responsibilities:
Review and Approval:
Conduct comprehensive evaluations of advertising and promotional content, encompassing digital media, print materials, and public relations communications, to ensure alignment with FDA regulations and industry standards.
Submission and Approvals:
Prepare and submit regulatory dossiers for product registration in both international and US markets. Oversee all facets of the submission process to secure timely product approvals.
Regulatory Strategy:
Formulate and execute regulatory strategies for promotional materials to enhance product positioning while ensuring compliance.
Regulatory Compliance:
Continuously monitor and ensure adherence to all international regulatory requirements and updates. Adjust strategies and processes as necessary to maintain compliance.
Cross-functional Collaboration: Work collaboratively with marketing, legal, and clinical teams to synchronize promotional strategies with regulatory requirements and business goals.
Regulatory Input in Design:
Offer expert regulatory insights during product design and development phases, ensuring that regulatory considerations are integrated from the outset.
Market Surveillance:
Manage post-market surveillance activities to guarantee ongoing compliance and safety of marketed devices. Coordinate incident reporting and recalls with local authorities.
Adverse Event Reporting:
Supervise the monitoring and reporting of adverse events and product complaints to relevant regulatory authorities across applicable international regions.
Audit Preparation:
Prepare for and support post-market compliance audits and inspections.
Training and Guidance:
Provide regulatory training and guidance to internal teams and stakeholders regarding international regulatory requirements and updates.
Stakeholder Engagement:
Engage with international regulatory authorities and organizations to facilitate processes and address inquiries. Cultivate and maintain positive relationships with regulatory representatives.
Communication:
Deliver regular updates to the management team and compile data specific to International Regulatory Affairs for the organization.
Manage the tactical execution of both short- and long-term objectives through coordinated activities with direct accountability for results.
Exhibit excellent interpersonal skills, demonstrating self-motivation and the ability to inspire others positively.
Maintain a focused, target-driven approach with a positive, can-do attitude.
Perform other duties as assigned.
Qualifications:
Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field is required; a Master's Degree is preferred. RAPS-RAC certification is advantageous.
Possess a minimum of 5-8 years of experience in a regulatory affairs capacity, particularly with Class II or Class III medical devices, with a strong focus on Advertising and Promotion and Standards review.
Demonstrated experience in regulatory submissions and registrations across multiple markets.
Strong comprehension of FDA and international regulatory standards, including ISO 13485 and risk management processes pertinent to medical devices.
Exhibit project management skills and experience.
Excellent organizational abilities, capable of managing multiple projects and timelines effectively.
Strong communication and interpersonal skills, with the capability to work collaboratively across diverse cultures and geographies.
Ability to thrive in a fast-paced and dynamic environment.
Proficient presentation skills, with both written and verbal communication capabilities.
Ability to draft clear, concise, and well-structured technical documents.
Computer Skills:
Proficient in MS Word, PowerPoint, Adobe Acrobat Professional, and Excel.
General Requirements:
The individual is expected to adhere to and support all company policies and procedures.
Ensure that their activities and those of their team comply with all legal and regulatory requirements applicable to the product lines and markets in which the company operates.
By joining Pulmonx, you become part of an organization that attracts and hires top talent globally. You will collaborate with a dedicated, friendly, and cooperative team, developing innovative and transformative products.
We are committed to the professional development and growth of our colleagues.
Pulmonx Corporation is an Equal Opportunity Employer that values 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.
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