Philips Regulatory Specialist 

Serbia, Central Serbia, Belgrade 

406369579

Regulatory SpecialistJob Description

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 youwill 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.

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.

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 andCentral and Eastern EuropeCountry 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)

Onsite roles require full-time presence in the company’s facilities.
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