Regulatory Affairs Manager — Medical Devices (Onsite)

Medtronic plc; Boston (MA); Vor Ort; USD 121.000 - 181.000; Vollzeit

Zusammenfassung

Medtronic plc is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and oversee submission activities focused on the U.S. and EU.

The role requires hands-on leadership and collaboration with cross-functional teams to meet regulatory objectives and product lifecycle goals. This onsite position supports Surgical Operating Unit submissions from multiple locations in the U.S.

Qualifikationen

• Bachelor’s degree required.
• Minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 of relevant experience.
• Experience with U.S. and EU regulatory submissions and regulatory strategy.

Aufgaben

• Lead regulatory submissions for U.S. and EU markets.
• Oversee regulatory activities and ensure compliance across the Regulatory Affairs team.
• Collaborate with quality, engineering, clinical, manufacturing and commercial teams to meet submission timelines.

Kenntnisse

Regulatory affairs

Cross-functional collaboration

Ausbildung

Bachelor’s degree

Jobbeschreibung

Medtronic plc is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and oversee submission activities focused on the U.S. and EU.

The role requires hands-on leadership and collaboration with cross-functional teams to meet regulatory objectives and product lifecycle goals. This onsite position supports Surgical Operating Unit submissions from multiple locations in the U.S.