Regulatory affair manager – Medical devices

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

Job Description: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.

Responsibilities:

• Develop and implement regulatory strategies for product development, registration, and commercialization.
• Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.
• Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
• Monitor and interpret changes in regulations and guidelines and communicate potential impact to relevant stakeholders.
• Manage regulatory documentation and maintain regulatory compliance records.
• Participate in regulatory audits and inspections as needed.
• Represent the company in regulatory interactions and meetings with regulatory agencies.

Qualifications:

• Bachelor’s degree in a scientific or healthcare-related field; advanced degree (e.g., Master’s or PhD) preferred.
• Minimum of [X] years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry.
• Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR), ICH guidelines, and other applicable regulations.
• Experience with regulatory submissions, including INDs, NDAs, 510(k)s, PMAs, or other regulatory filings.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
• Regulatory Affairs Certification (RAC) preferred.