Regulatory Affairs Specialist

Job ID: 12345 Location: Minneapolis, MN Type: Full-time About the Role The Regulatory Affairs Manager ensures that all documentation and submissions for cardiovascular devices meet US and international regulatory standards. They act as the primary liaison with regulatory bodies, guiding the company through the complex regulatory landscape. Responsibilities • Develop and enforce documentation policies to ensure compliance with US, EU, and Canadian regulations for cardiovascular devices • Prepare, submit, and track regulatory submissions including FDA 510(k), CE Technical Documentation, and Canadian Device Applications • Serve as the primary contact with regulatory agencies, addressing inquiries and negotiating submission issues • Review product changes, engineering change orders, labeling, and promotional materials to maintain compliance • Provide regulatory guidance and support to product development teams throughout the product lifecycle • Monitor and interpret new and updated regulations, ensuring company-wide adherence • Mentor junior regulatory staff and foster a culture of compliance and continuous improvement • Collaborate with cross-functional teams to resolve regulatory challenges and mitigate risks Requirements • Bachelor’s degree in a scientific, engineering, or related field • Minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on cardiovascular devices preferred • Proven experience authoring and managing regulatory submissions (e.g., FDA 510(k), CE Marking, Canadian Licensing) • Strong understanding of regulatory standards and frameworks, including ISO 13485, ISO 14971, and IEC 62366 • Excellent written and verbal communication skills in English; proficiency in additional languages is a plus • Ability to interpret complex scientific and technical information and translate it into regulatory strategies • Demonstrated leadership skills with experience mentoring junior staff • Detail-oriented with strong organizational and project management abilities Nice-to-Have • Advanced degree (e.g., Master’s or PhD) in a relevant field • Experience with international submissions beyond the US, EU, and Canada • Familiarity with software as a medical device (SaMD) regulations • Certification in regulatory affairs (e.g., RAC) • Experience working in a fast-paced, innovative environment with agile methodologies

If you are passionate about ensuring the safety and efficacy of medical devices while navigating the evolving regulatory landscape, we encourage you to apply.

At XYZ Medical, we value diversity and are committed to creating an inclusive environment for all employees.

XYZ Medical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

**Note:** Beware of scams. We will never ask you to pay for a job application or interview process.

**Application Instructions:** To apply, please submit your resume and a cover letter outlining your relevant experience to careers@xyzmedical.com.

**EEO Statement:** XYZ Medical is an equal opportunity employer and does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.

Location: Minneapolis, MN – Full-time

About the Role

The Regulatory Affairs Manager ensures that all documentation and submissions for cardiovascular devices meet US and international regulatory standards. They act as the primary liaison with regulatory bodies, guiding the company through the complex regulatory landscape.

Responsibilities

• Develop and enforce documentation policies to ensure compliance with US, EU, and Canadian regulations for cardiovascular devices
• Prepare, submit, and track regulatory submissions including FDA 510(k), CE Technical Documentation, and Canadian Device Applications
• Serve as the primary contact with regulatory agencies, addressing inquiries and negotiating submission issues
• Review product changes, engineering change orders, labeling, and promotional materials to maintain compliance
• Provide regulatory guidance and support to product development teams throughout the product lifecycle
• Monitor and interpret new and updated regulations, ensuring company-wide adherence
• Mentor junior regulatory staff and foster a culture of compliance and continuous improvement
• Collaborate with cross-functional teams to resolve regulatory challenges and mitigate risks

Requirements

• Bachelor’s degree in a scientific, engineering, or related field
• Minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on cardiovascular devices preferred
• Proven experience authoring and managing regulatory submissions (e.g., FDA 510(k), CE Marking, Canadian Licensing)
• Strong understanding of regulatory standards and frameworks, including ISO 13485, ISO 14971, and IEC 62366
• Excellent written and verbal communication skills in English; proficiency in additional languages is a plus
• Ability to interpret complex scientific and technical information and translate it into regulatory strategies
• Demonstrated leadership skills with experience mentoring junior staff
• Detail-oriented with strong organizational and project management abilities

Nice-to-Have

• Advanced degree (e.g., Master’s or PhD) in a relevant field
• Experience with international submissions beyond the US, EU, and Canada
• Familiarity with software as a medical device (SaMD) regulations
• Certification in regulatory affairs (e.g., RAC)
• Experience working in a fast-paced, innovative environment with agile methodologies