Regulatory Affairs Manager EMEA Uppsala, Sweden

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Vision

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments Ready to join a team thats reimagining how vision is improved Our Vision team solves the toughest health challenges. Help combine cutting-edge insights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at Affairs Manager EMEA Vision Care Uppsala Sweden

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.

Please note that a pre-identified candidate for consideration has been identified. However all applications will be considered.

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 RArelated aspects
• Ensure labeling and packaging compliance for both new and existing products

Qualifications & Experience

• Education
• University degree in Life Sciences Pharmacy Medical device Engineering or another relevant scientific discipline
• Experience
• Strong regulatory knowledge especially in EMEA medical / medical Device products regulations and 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
• Handson 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

Skills & Competencies

• Strong analytical skills and attention to detail
• Ability to manage regulatory activities in a complex crossfunctional 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 advantage)

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer 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. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.