Senior Specialist, Regulatory Affairs

Overview

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

• Using a broad base of knowledge and understanding of regulatory requirements, will assume major responsibility for supporting new product development.

• Utilizing an advanced base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.

• Provide regulatory input to cross-functional teams. Works independently to evaluate regulatory issues, develop and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions.

• Lead in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions. Author draft submissions (510k, PMA, BLA) with minimal supervision.

• Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Under minimal supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements.

• Interact with Regulatory Body personnel with minimal supervision. Actively lead 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.

• Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.

• 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 the RA lead and work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations.

• Lead rollouts of product changes with corporate and international regulatory teams.

• Lead Unique Device Identification system requirements and other labeling compliance of new products introduced into the market. Plan and coordinate rollouts of product changes with corporate and international regulatory teams.

• 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. Problem solving:
  Apply company policies and procedures to resolve a variety of issues of increasing complexity;
  Provide solutions to a variety of problems of moderate to high complexity. 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.

• Bachelor's degree in science, Engineering, Regulatory Affairs, or other technically related field.

• Minimum of 3-5 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 2 years in Regulatory Affairs and the remaining years can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met:

• RA Certification (RAC) can count towards 1 year of specific RA experience

• Master's degree can count towards 2 years of relevant (non-RA) experience

• Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.

• Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams).

• Strong working knowledge of domestic and/or international…