Senior Regulatory Affairs Specialist
This position offers valuable experience with the US and EU across a variety of technically interesting medical devices, which are either under development or commercially available.
Primary responsibilities are to ensure regulatory compliance for assigned product lines. Other responsibilities include identifying relevant standards and guidance documents that affect the Company’s business and products. Performs duties with limited input from management and/or senior members of the department.
- Participates on various teams to define and share regulatory requirements of the EU, U.S. and international regions.
- Prepares regulatory submissions to the Notified Body, the FDA, and other regulatory authorities.
- Interacts with various levels of management, external agencies and companies.
- Develops, maintains and analyzes department systems and provides training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Performs other related duties and tasks, as required.
Summary of Minimum Qualifications:
- Education and experience equivalent to a Bachelors’ Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
- Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Device Regulation (2017/745, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485 and MDSAP.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Good technical competency on manufacturing systems and design controls.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
- Location: Role is 100% remote, with option of on-site (hybrid)
To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E: firstname.lastname@example.org
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