Nationwide Technical Resources Corp (11-50 Employees, 2 Yr Employee Growth Rate)
Number of Positions
This is a remote position.
Seeking a Regulatory Affairs Specialist for a global leader design, development, and manufacture of chemical and electronics-based medical devices in Suffolk County, Long Island NY.
*This position is remote with possible quarterly (at most) visits on-site for a few days for product training and audit support.
This is a fast-paced-team environment with a strong company commitment to R&D and to developing first-class products in a highly-competitive, FDA- and global- regulated field.
The Regulatory Affairs Specialist leads and/or assists in drafting, submitting, and gaining clearance for 510(k) applications for class II medical devices. The role also involves drafting CE Technical Files, Clinical Evaluations, and other critical regulatory documents for a global medical/dental device designer & manufacturer. The Regulatory Affairs Specialist must develop and maintain an active working knowledge of the company’s products, as well as of relevant U.S. and foreign regulations and guidance documents.
- Prepare, review and maintain international Regulatory submissions, including CE Technical Files and Design Control documents, and other international documents, to obtain and maintain market access.
- Create and submit documents and timely responses with international Regulatory bodies, in accordance with local and international regulations.
- Support QA Manager as needed in QMS activities: internal audits, CAPA system, Complaints, and SOP revisions.
- Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations.
- Creation, review, and submission of product files for foreign market registration.
- Review design changes and technical files for updates to documentation.
- Ensure conformance to ISO, CE, FDA and other international/local regulations.
- BS degree in Chemistry, Electrical Engineering or health or science-related field. Engineering degree is a plus.
- Minimum of 2 years’ experience in the medical device industry OR in International Regulatory Affairs for the medical device industry.
- Ideally, has knowledge of requirements in accordance with FDA, MDD/MDR, International standards: ISO 13485, MDSAP, and guidance documents (MEDDEVs).
- Self-starter with excellent ability to work independently with little oversight, as well as excellent organizational, planning, and follow-up skills.
- Strength in prioritizing and handling several projects concurrently and in meeting deadlines.
- Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization.
- Ability to maintain confidentiality in dealing with regulatory and clinical documentation.
- Strong technical system skills (e.g., word documents, spreadsheets, online research)
Competitive compensation package and benefits including excellent health, dental, vision coverage FSA, HSA, 401K and pension plan.