Job description

Regulatory Affairs Specialist

Schaumburg, IL

Medical Device Manufacturing

Start date: ASAP

Salary range - $75,000 - $95,000 (DOE)

I’m working with a leading manufacturer of Medical Device products, based in Schaumburg, IL and they are looking for a Regulatory Affairs Specialist to join their expanding team. This is an international client that have flourished in recent years and hiring quite heavily at the moment to take the next steps in their expansion.

This would be an excellent opportunity for the right candidate to join a well-established business that are going from strength to strength.

If you’re looking for a company to build a long lasting and successful team, this is the opportunity for you. They promote from within to allow for tangible career growth and opportunities. The reason they are so happy to promote from within is that they have excellent training programs and leadership teams who are committed to the company and their quest to be the best!

Main Responsibilities

· Coordinate, compile, and submit regulatory documents to competent authorities.

· Notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files.

· Work with Manager, Regulatory Affairs to ensure rapid and timely approval of new products.

· Continued regulatory support of products marketed outside the United States

· Work to support and ensure regulatory compliance across LATAM region for a broad product portfolio including medical devices, consumer packaged goods, drugs and cosmetics.

· Assist with the development of the LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.

· Support and make recommendations for projects by working closely with LATAM functional partners and Manager Regulatory Affairs to move projects from discovery to launch.

· Under supervision, evaluate proposed product modifications for international regulatory impact, completing regulatory assessments as needed.

· Ensure compliance with applicable international regulations and standards

· Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

· Under supervision, prepare responses to health authority questions and other regulatory correspondence.

· Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.

· Update and maintain FDA/Health Canada Establishment Registration and Listing, as well as State licensing

· Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

Qualifications

· BS in Science/Technology or higher

· Minimum of 2 years of related experience with Medical Devices

· Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, Canada and Europe) is desired

· Minimum 1 year of experience with 21 CFR 820, 807, 11, 701; ICH, ISO 13485:2016 and ISO 14971

· Familiarity with application of US Federal Food, Drug, and Cosmetic Act (FD&C), Section 510(k) is required.

· Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required; EU MDR familiarity is desired.

· Working knowledge of Regulatory Authority computerized submission systems

· Solid writing ability and good verbal communication skills

· Proficiency in MS Office

· Good interpersonal and organizational skills

· Some domestic or international travel may be required.

· Ability to travel and drive a car to attend meetings and seminars

Job Type: Full-time

Salary: $80,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Schaumburg, IL 60173: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 2 years (Preferred)
• International product registration: 1 year (Preferred)
• Medical Device: 2 years (Preferred)

Work Location: One location

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