[Hiring] Regulatory Affairs Manager EMEA @Johnson & Johnson Innovative Medicine

Role Description

We are now looking for a Regulatory Affairs Manager to join our Vision Care organization in Uppsala, Sweden . In this influential role, you will play a vital part in enabling safe, compliant, and timely access to innovative medicinal products and medical devices across the EMEA region. You will work closely with regional and global stakeholders, contributing your regulatory expertise to support product launches, lifecycle activities, and continuous improvement in a highly regulated and impactful environment.

Objectives of the Position

• Regulatory Strategy & Compliance
  • Apply scientific, regulatory, and business knowledge to ensure compliance for medicinal products and medical devices throughout their life cycle.
  • Ensure adherence to European regulations (including MDR) and applicable national EMEA requirements.
• Regulatory Submissions & Registrations
  • Prepare, assemble, and submit regulatory applications to Competent Authorities and Notified Bodies to achieve and maintain product registrations within EMEA.
  • Prepare, review, and approve registration dossiers, technical documentation, and labeling materials (e.g. package inserts) prior to submission.
• Change Control & Lifecycle Management
  • Participate in site change control processes and ensure regulatory impact assessments are received and properly filed from all global regions.
  • Manage and submit regulatory change notifications and approvals to authorities prior to implementation.
• Collaboration & Regional Support
  • Work closely with the Director, Regulatory Affairs EMEA, to support regional regulatory projects and initiatives.
  • Provide Regulatory Affairs support for local registrations and market authorizations in individual EMEA countries.
  • Support other regional RA teams relying on European registrations.
• Manufacturing, Audits & Distribution
  • Ensure regulatory distribution release activities for medical device products.
  • Support inspections and audits by Competent Authorities and Notified Bodies at manufacturing sites, focusing on RA-related aspects.
  • Ensure labeling and packaging compliance for both new and existing products.

Qualifications

• University degree in Life Sciences, Pharmacy, Medical Device Engineering, or another relevant scientific discipline.
• Strong regulatory knowledge especially in EMEA medical / medical device products regulations.
• Ideally experience in CE marking of medical devices (class IIa and above; for 4-6 years); experience with CE marking of ophthalmic medical devices is of advantage.
• Managerial responsibility (at least 2 years) – including supervisor responsibility.
• Hands-on experience with regulatory submissions to Competent Authorities and/or Notified Bodies.
• Solid understanding of European regulatory frameworks, including MDR.
• Experience supporting product lifecycle management and change control processes.

Requirements

• Strong analytical skills and attention to detail.
• Ability to manage regulatory activities in a complex, cross-functional, and international environment.
• Clear and confident communication skills, both written and verbal.
• Comfortable working independently while collaborating closely with regional and global stakeholders.
• Fluent in English both written and verbal (Swedish is an advantage).

Benefits

• Annual bonus with set target (% of pay) depending on pay grade/location, based on employee and company performance.
• Vacation days.
• Parental leave for a minimum of 12 weeks.
• Bereavement leave.
• Caregiver leave.
• Volunteer leave.
• Well-being reimbursement.
• Programs for financial, physical, and mental health.
• Service anniversary and recognition awards.
• Participation in several insurance plans for employees and eligible dependents.