Regulatory affair manager – Medical devices

Job Description

: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.

Responsibilities:

Develop and implement regulatory strategies for product development, registration, and commercialization.

Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.

Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.

Provide regulatory guidance and sup...