Sr. Regulatory Affairs Specialist (REMOTE)

Hiring a FULLY REMOTE Regulatory Affairs Specialist

Description

We are a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. We aim to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements. The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and EU. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, ensures that registration/renewal deadlines are met, and supports new product development.

Essential Job Functions

· Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.

· Outline submission and approval requirements in assigned geographies.

· In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes.

· Provide regulatory input and technical guidance to product development and operations teams.

· Work with product development, quality and operations functions to identify applicable regulations/standards  and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21  CFR, regulatory agency guidance documents).

· Review and approve R&D, quality, preclinical and clinical documentation for submission filing(s).

· In collaboration with cross-functional team members, compile, prepare, review and submit high-quality  regulatory submissions to authorities on time in US and EU. Support international regulatory team with  submissions to other geographies (e.g., Canada, Australia, Japan, etc.).

· In consultation with responsible Regulatory Affairs Management, interact and negotiate with regulatory  authorities during the development and review process to ensure submission approvals.

· Communicate application progress to internal stakeholders.

· Review labeling and labels for compliance with regulatory requirements.

· Evaluate and maintain current regulatory policies, processes, procedures.

· Commensurate with the level of experience, effectively communicate, prepare, and negotiate both internally  with cross-functional teams and externally with various regulatory agencies.

· Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in  compliance with Regulatory requirements.

· Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.

· Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.

· Provide regulatory input for product recalls and recall communications.

· Support quality system and technical file/design dossier audits.

· Maintain regulatory files and tracking databases as required.

· Evaluate import/export requirements.

· Identify emerging issues.

· Provide other US and EU country specific regulatory support.

· Effectively and accurately write and edit technical documents.

· Plan and conduct meetings, create project plans and timelines, and manage projects.

· Exercise good and ethical judgment within policy and regulations.

· Perform multiple tasks concurrently with accuracy.

· Provide guidance to functional groups in the development of relevant data to complete a regulatory    submission.

· Maintain current knowledge of FDA and EU regulations, guidance and standards applicable to company  products.

· Ensure personal understanding of all quality policy/system items that are applicable. Follow all work/quality  procedures to ensure quality system compliance and high-quality work.

· Other duties as assigned.

Requirements

· Bachelor's degree in science, math, engineering, or medical fields is preferred. Post-graduate degree in a technical area, M.B.A. or law is preferred.

· Minimum 4 years of regulatory affairs experience in the medical device industry. Class III medical device experience preferred.

· Ability to work collaboratively in a fast-paced environment while managing multiple priorities.

· Must be able to travel as needed, approximately 2-3 times a year.

· Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.

· Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and Technical Documentation.

· Commensurate with the level of experience, ability to outline sound regulatory strategy in alignment with regulations and business priorities.

· Clear and effective verbal and written communication skills with diverse audiences and personnel.

· Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

· Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks.

· Operate as a team member and/or independently while demonstrating flexibility to changing requirements.

· Some medical device software engineering background or experience is preferred.

· Proficiency in MS Word, Excel, Adobe and Power Point.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.