Job Title: Principal Regulatory Affairs Associate
Location: Remote
Contract length: 12 months
Pay rate: Flexible
Job Summary:
The Principal Regulatory Affairs Associate will play a pivotal role in ensuring our clients medical devices meet all applicable regulatory requirements for market access and post-market compliance. This individual will be a key contributor to regulatory strategy, submissions, and ongoing lifecycle management.
Job Responsibilities:
* Represent Regulatory Affairs on product development teams to support new product development and change control, ensuring compliance with US, EU, and other global regulatory requirements.
* Author EU technical documentation under MDR, FDA submissions (e.g., 510(k)) and other global regulatory filings.
* Evaluate medical device regulations and lead the development of global regulatory strategies to bring products to market.
* Review and approve design control documentation in consideration of US, EU, and other global regulatory requirements.
* Develop and implement global regulatory strategies for assigned product portfolios, ensuring alignment with business objectives and compliance with relevant regulations.
* Act as a primary regulatory liaison with internal teams (R&D, Quality, Marketing, Clinical Affairs).
* Provide expert regulatory guidance and interpretation of regulations, standards, and guidance documents to cross-functional project teams throughout the product lifecycle.
* Monitor and assess changes in global regulatory landscapes, evaluating their impact on products and processes, and developing strategies to address them.
* Participate in and/or lead regulatory reviews of product labeling, promotional materials, and marketing claims to ensure compliance.
* Contribute to the development and improvement of internal regulatory procedures and processes.
* Mentor and provide guidance to regulatory affairs associates as required.
* Participate in internal and external audits as a regulatory subject matter expert.
Required skills & experience:
* Bachelor's degree in a scientific discipline or equivalent relevant experience.
* Experience in Regulatory Affairs within the medical device or IVD industry, with a strong emphasis on EU and US regulations.
* Demonstrated experience in leading complex regulatory submissions (e.g., CE Mark, 510k, PMA, Q-Sub) and other global regulatory agencies.
* Strong understanding of relevant international standards (e.g., ISO 13485, ISO 14971, IEC 62304).
* Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly and concisely to diverse audiences.
* Proven ability to work independently, manage multiple projects simultaneously, and meet tight deadlines.
* Strong analytical, problem-solving skills.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
* Ability to work effectively in a global, matrixed organization.