Responsible for supporting Philips Central and Eastern Europe (CEE) Country Sales, Solutions, and Service compliance to applicable regional regulations. The scope includes general product, medical devices, IVDs, cosmetics, trade compliance, other applicable regional regulations implemented by local Regulators in Serbia, Bosnia & Herzegovina, Montenegro, Macedonia, Albania, Kosovo and EU Competent Authorities and government agencies, in addition to device regulations from agencies such as the U.S. Food and Drug Administration.
Responsible for implementation of the local country Regulatory Processes in the Quality System applicable to CEE sales, solutions and service regulations. As part of the Regulatory team interfacing within Philips legal manufacturers and the wider International Markets Regulatory organisation.
Collaborating with commercial teams and Philips Partners to align on go to market strategy ensuring regulatory compliance and market access.
Ensuring customer requirements are met including reimbursement, private and public healthcare requirements, and consumer needs.
Facilitating the legalisation and submission of regulatory documentation direct to Regulators or through third parties to Regulators.
As the RA Manager based in Serbia you will act on behalf of the Philips legal manufacturers to support distribution across specific CEE countries.
As the RA Manager you will have experience of regional and EU regulatory requirements for medical devices and IVDs. Further knowledge of other regulations such as general products, cosmetics, Radiation Protection, Trade Compliance, Export Controls, Hazardous and Dangerous Goods, Information Technology Service Management, Digital and Healthcare Standards and Regulations would be an advantage.
Your Responsibilities
Regulatory Affairs
Monitoring local regulatory landscape that impacts Philips and translate and implement these regulations into the business.
Provide continuous regional regulatory updates to applicable stakeholders and partner with regional commercial, supply chain and Philips legal manufacturer regulatory teams to ensure end to end compliance.
Build Relationships with Distribution and Service Partners to facilitate regulatory compliance and market access through advocacy, assessment, implementation, and monitoring of applicable regulations.
Engage in product, solutions and services development and lifecycle to ensure regulatory compliance.
Lead regulatory compliance as appointed by the country legal entities to support changes in Regulations
Lead Regulatory registration and company self assessments where required with Government Agencies as applicable for products, solution and services in the applicable country.
Liaise with EU Authorised Representative in delivering regulatory responsibilities.
Liaise with Post Market Surveillance team to ensure awareness of communication with Regulators and if required support any escalations.
Build relations with Regulatory and Compliance subject matter experts within Philips and externally engaging Trade Associations and Regulators where applicable.
Lead change in culture and facilitate regulatory compliance.
Quality Management
Local lead for country transition of global programs related to Regulatory processes into the Markets QMS
Ensures traceability between Regulatory processes within Philips Excellence Process Framework and the Markets QMS
The RA representative in projects to drive local compliance with the applicable country regulations and global alignment with Philips standards & policies.
Provide Regulatory input and report out to the management team and management review
Support with relevant regulatory inspections and quality management system audits and follow up with formal response to any findings that impact Regulatory.
We are looking for
Education & Experience
Successfully completed Bachelor or Master’s program or equivalent
Demonstrable experience within medical device/IVD regulatory domain (other related regulated industry experience such as clinical, medicines, information technology, trade compliance would be an advantage and will be considered)
Fluent in Serbian and English both verbal and written. Additional languages would be an advantage and will be considered.
Competencies required
Excellent verbal and written communication skills and demonstrated customer relation skills.
Working knowledge of relevant EU and Central and Eastern Europe Country Regulations (general product, medical devices, IVDs, cosmetics, and preferably other applicable Regulations in Radiation Protection, Trade Compliance, Export Controls, Dangerous Goods, Information Technology Service Management, Healthcare Standards and Regulations).
Ability to translate regulation into operational process.
Computer skills including database management, word processing and spreadsheets are also necessary.
Rigorous and precise work is compulsory.
Team player
Able to analytically assess impact to the business and the ability to quickly understand and influence
Experience in influencing regulations
Able to proactively and independently resolve issues in a compliant way
Able to communicate across levels and cultures internally within Philips and externally representing Philips (stakeholder management)
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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