Regulatory Affairs Manager (Hybrid)

About Spectrum Vascular

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a
company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and
growing team with established products and an entrepreneurial mindset.

Role Description:

The Regulatory Affairs Manager is a seasoned professional responsible for contributing to and implementing regulatory strategies and tactics for the Company with a focus on achieving product registrations as well as assuring compliance to product claims for all current and new product submissions in the US and globally. The Regulatory Affairs Manager is responsible for the development and submission of regulatory documentation for maintaining registrations associated with the the current product portfolio, as well as new product submissions. to ensure that regulatory requirements are met.

Key responsibilities:

· Act as a primary contact for regulatory affairs on cross-functional product development and post-marketing teams and support submission activities throughout product development and lifecycle.

· Manage and work with minimal supervision to help bring medical devices to market and ensure ongoing Regulatory Affairs compliance.

· Participate on cross-functional teams and develop US and global regulatory strategies.

· Author regulatory submissions, interact with regulatory agencies/notified bodies, review labelling and marketing materials, and evaluate proposed device changes.

· Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Work independently to evaluate regulatory issues and revise technical documentation for existing and new regulatory submissions.

· Anticipate and manage regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

· Provide regulatory input and technical guidance for product development and planning throughout the product lifecycle.

· Assess the acceptability of quality, preclinical, and clinical documents for submissions to comply with applicable regulations.

· Evaluate proposed changes for regulatory submissions and propose strategies for changes that do not require submissions.

· Author draft submissions (510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs including ensuring prompt follow-up to the questions and requests received from regulators.

· Under minimal supervision, assist with the coordination, preparation, and maintenance of FDA 510K filings in accordance with US FDA requirements. Interact with Regulatory Body personnel in collaboration with the Chief Operating Officer/ Sr. VP Regulatory Affairs.

· Support the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews.

· Develop regulatory strategies around ad/promo reviews based on regulations; review promotional and advertising material for adherence to approved product claims and regulatory compliance.

· Serve as RA lead and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971.

· Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.

· Work independently to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations.

· Participate in and lead continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned.

· Contribute to the authoring of SOPs and train key personnel as needed.

· Perform other duties as assigned.

Competencies:

· Able to work independently as well as collaboratively to partner with, influence and inspire others

· Thinks analytically and strategically to formulate, develop, and execute clinical plans

· Experienced with engaging internal and external experts in constructive scientific and clinical dialogue around study design, study conduct, and interpretation of clinical results

· Demonstrates high integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality

· Adaptable to respond to constantly changing regulatory procedures and prioritize work effectively.

Qualifications:

· A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

· A minimum of 5 years of experience in an FDA-regulated industry required; preferably with medical devices.

· Advanced Degree preferred.

· Previous experience with submitting 510ks and/or PMAs required

· Strong understanding of product development process and design control.

· Thorough understanding of FDA and international medical device regulations.

· Strong knowledge of FDA medical device Regulatory Affairs requirements

· Experience interacting with Regulatory Agencies and Notified Bodies required.

· Excellent scientific written and verbal communication skills.

· Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Work Environment:

· Remote-based

· Dynamic, interactive, fast-paced, and entrepreneurial environment

· Travel – up to 25%??, additional may be required during execution of validation activities

Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion,
national origin, age, veteran status, or any other protected status under the law.