FDA Compliance Specialist

Job description

Ontel Products Corporation seeks a highly motivated and detail-oriented individual with extensive knowledge of and experience in launching consumer goods and food items by the Food and Drug Administration’s regulatory requirements. The ideal candidate will have experience complying with the FDA’s Good Manufacturing Practice Requirements outlined in the Quality System Regulation (21 C.F.R. Part 820) and the ability to assist Ontel with product registration, product packaging review, marketing review, and compliance requirements. We are looking for a true leader in the space who can help our ever-growing corporation adopt new protocols and procedures while ensuring a seamless launch of food and non-food items.

Responsibilities:

- Prepare and submit medical device registration applications to the FDA, ensuring compliance with FDA regulations and guidelines

-Expand upon the internal protocol related to Good Manufacturing Practice Requirements for Ontel food products and consumer goods

- Manage all communications with the FDA related to medical device and food registration activities, including submission status updates, requests for additional information, and necessary follow-up actions

- Maintain FDA documentation related to medical device registration activities, including device and food listings, establishment registration, and product labeling, and ensure compliance with document retention requirements

- Provide guidance and support to internal cross-functional teams related to FDA regulations and compliance as it pertains to registration, product packaging, marketing claims, and customer service requirements

- Work with the customer service team to ensure that all inquiries related to applicable products are handled in an efficient and timely manner

-Should a government inquiry occur, partner with inside and outside counsel and relevant development teams to ensure accurate and timely responses

Qualifications:

- Minimum bachelor’s degree required. An appropriate technical field or legal experience is preferred.

- At least 4 years of direct experience in FDA medical device regulatory affairs, registration, or related work experience

- Strong knowledge of relevant regulations and guidelines (i.e., 21 C.F.R. 820, 21 C.F.R. 807, 21 C.F.R. 890.5700)

- Experience with registration and compliance processes (e.g., 510(k), PMA, CE mark, MDSAP)

- Strong communication and interpersonal skills

-Quick decision maker. You must be efficient and able to quickly make high-pressure decisions independently.

- Excellent attention to detail and accuracy

- Strong analytical and problem-solving skills

-Excellent written command of the English language required, as employee will be required to draft and send legal communications to the appropriate governmental body.

This role will report to Ontel Products Corporation's General Counsel. This is a full-time, remote position with a competitive salary and benefits package, including health insurance, retirement plans, and paid time off. If you are passionate about compliance and are looking for an exciting and challenging opportunity, we encourage you to apply.