Responsible for Company’s Regulatory Affairs programs and efforts managing submissions to regulatory authorities worldwide in compliance with FDA and OUS guidelines and regulations. Responsible for the global regulatory compliance. Plans, develops, and performs activities to support Regulatory submissions and inquiries compliantly. In addition, assists the Senior Director in support of Quality Assurance and Quality Systems objectives as appropriate.
- Develop regulatory strategies for new or modified products. Ensures alignment of regulatory strategy to business strategy across all functional areas.
- Prepares reviews and submits all necessary regulatory information to FDA and OUS regulatory bodies including but not limited to 510(k)’S, IDE’s, PMA’s, and other OUS requirements.
- Develop and implement checklists for use to include audit points covering FDA, OUS, and other international regulatory requirements, as appropriate.
- Provides regulatory direction and strategy to new product project teams.
- Reviews all promotional and advertising material and provides regulatory direction for communications to the sales force and training department relating to marketed products.
- Create and update Technical Documents, Clinical Evaluation Reports, Post-Market Clinical Follow-up and Periodic Safety Update Report following EU MDR requirements.
- Review all Change Notifications for regulatory requirements.
- Participates in new product development with core team as primary regulatory representative.
- Proposes the required regulatory component for each product development project plan.
- Keep informed of new and pending requirements by researching regulatory requirements germane to the company.
- Implements corporate regulatory policy by updating regulatory operating procedures and provides assistance to other departments within the company regarding regulatory aspects of product development.
- Reviews applicable FDA regulatory proceedings and maintains awareness of required regulatory changes as adopted and reports potential impact of changes to the Senior Director and communicates same to the senior leadership of the company.
- Address questions, observations and recommendations resulting from audit findings and provide expertise and assistance in formulating systemic, corrective, and preventive action for any findings to ensure regulatory compliance as applicable.
- Manages regulatory compliance inquiries and visits to insure a satisfactory resolution to any issues.
- Create, update, and revise SOPs as needed to ensure Regulatory compliance as applicable.
- Works under direct supervision of the Senior Director in communicating directly with regulatory agencies, ensuring the success of regulatory submissions and filings.
- Other assignments and projects as directed.
- Bachelor’s degree required (Life Science preferred)
- Minimum five years regulatory experience with FDA and ISO regulations and a strong knowledge of the medical device industry.
- FDA 510(k) submission experience required
- Extensive current knowledge of FDA, device pre-market notification and device CE certification requirements for the European Union.
- Regulatory project management experience required; supervisory management experience preferred
- Strong communication, team building, written and verbal communication skills, and interpersonal & problem-solving skills
- Ability to exercise sound judgment in prioritizing workflow
- Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.
- Detail & deadline oriented, well organized; demonstrated ability to clearly organize, plan and schedule tasks and communicate status of projects in a timely manner.
EndoGastric Solutions, Inc. is committed to recruiting individuals who believe in team work, achievement and excellence. We strive to attract and retain employees of the highest caliber based on abilities, achievements and experience.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status. EndoGastric Solutions takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.
Interested candidates should submit their resume and cover letter to Human Resources: