Regulatory Affairs Specialist

Regulatory Affairs Specialist – Onsite
We are seeking a highly experienced (Sr) Regulatory Affairs Specialist to lead global regulatory strategy and submissions for innovative medical devices. This role is ideal for a regulatory professional who thrives in a fast-paced environment and is passionate about shaping the future of healthcare through compliance and strategic leadership.

Who you are

• Develop and communicate global regulatory strategies for complex medical devices and major product updates, ensuring alignment with internal teams and leadership.
• Lead the preparation and submission of international regulatory documentation and represent the company in high-level discussions with regulatory authorities.
• Guide internal teams on compliance with global regulatory standards and oversee quality system adherence across product development and post-market activities.

What you’ll do

• Minimum of 3–5 years of regulatory affairs experience in the medical device industry, depending on academic background (BS, MS, or PhD).
• Proven track record in managing major regulatory submissions (e.g., PMA, IDE, EU Design Dossiers) and navigating FDA and international regulatory frameworks.
• Strong leadership, communication, and project management skills, with the ability to mentor junior staff and collaborate across multidisciplinary teams.

What does this position pay?

• Compensation is determined by several factors which may include skillset, experience level, and geographic location. The expected range for this role is $85k – $100k annually. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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