Strategic Regulatory Affairs Manager

Approach People; Genf; On-site; CHF 130,000 - 170,000; Full time

Job summary

Approach People Recruitment is seeking a Regulatory Affairs Manager to lead regulatory strategy across pharmaceutical, medical device, or healthcare products. You will prepare filings, liaise with authorities, and guide cross-functional teams to ensure product compliance through development, approval, and post-market phases.

The role requires strong experience with regulatory submissions (IND/NDA, 510(k), PMA) and a proactive approach to monitoring changing regulations, while maintaining

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field; advanced degree preferred.
• Experience with regulatory submissions (IND/NDA, 510(k), PMA) and regulatory guidelines (FDA/ICH).
• Excellent communication and collaboration skills across R&D, QA, Clinical Affairs, and Marketing.

Responsibilities

• Develop and implement regulatory strategies for product development, registration, and commercialization.
• Prepare and submit regulatory submissions (IND, NDA, 510(k), PMA) and other filings.
• Liaise with regulatory agencies (FDA, EMA) to facilitate reviews and approvals.
• Provide regulatory guidance to cross-functional teams to ensure lifecycle compliance.
• Monitor regulatory changes and communicate impacts to stakeholders.
• Maintain regulatory documentation and compliance records.
• Support regulatory audits and inspections as needed.
• Represent the company in regulatory interactions and meetings with agencies.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory liaison

Audits & inspections

Education

Bachelor’s degree in science/healthcare

Master’s or PhD preferred

Job description

Approach People Recruitment is seeking a Regulatory Affairs Manager to lead regulatory strategy across pharmaceutical, medical device, or healthcare products. You will prepare filings, liaise with authorities, and guide cross-functional teams to ensure product compliance through development, approval, and post-market phases.

The role requires strong experience with regulatory submissions (IND/NDA, 510(k), PMA) and a proactive approach to monitoring changing regulations, while maintaining