Regulatory Specialist

Gravitiq is seeking a dedicated Regulatory Specialist to join our compliance regulatory team, focusing on medical devices and other product categories for global markets, including but not limited to the US, Canada, the UK, and the EU (Spain, Germany, France, Italy). This role is crucial in ensuring compliance with legal and regulatory requirements as we expand our operations globally. The Regulatory Specialist will assist with various regulatory tasks and support the team's daily activities.

Responsibilities:

· Collaborate within the compliance team to identify and assess compliance risks specific to the medical device industry or any other assigned product category.

· Support new product launches & market expansions, maintain products, and ensure compliance with legal requirements for assigned categories. Prepare, collate & regularly maintain Declaration of conformity documents, Technical files, FDA/ GUDID/ EUDAMED notifications/compliances/actor registrations, SRN’s, UDIs & mandates.

· Review and ensure compliance of assigned product categories with global regulatory requirements, advising on necessary edits to product descriptions, packaging/labeling materials, electronic listings, & marketing materials. Stay abreast of compliance requirements and resolve compliance/ performance notifications for online marketplaces like Amazon/ Tik Tok/ Others.

· Regularly review, audit, and proactively maintain supplier documents and certifications, ensure compliance of materials, assist in claims support, conduct supplier audits, product and material testing, labelling/ packaging compliances & claims settings. Maintain working relationships and communicate, as appropriate, with our suppliers and Responsible Person contacts for compliance projects.

· Conduct research and gather relevant information to support compliance efforts for the international operations of our entities and for our products. Monitor and evaluate compliance with regulations in target markets. Assist in the development and implementation of compliance policies and procedures tailored to the device market and any other assigned product categories. Provide regular updates and reports on compliance status, & any regulation changes along with associated actions to the compliance regulatory team and the wider teams as appropriate.

· Ensure compliance with Quality Management System (QMS) requirements and regulatory standards applicable to medical devices/any other product categories, including maintaining accurate detailed documentation, and records related to compliance activities, alongside supplier documents, handling complaints, and supporting quality assurance activities.

· Manage communication and correspondence related to compliance matters, including liaising with regulatory bodies or authorities.

· Schedule meetings, confirm appointments, maintain regulatory summaries, organize compliance-related meetings, and undertake other responsibilities as assigned by the compliance regulatory team.

Regulatory Specialist Requirements:

· Minimum 3–6 years of relevant experience in the regulatory field, preferably within the medical device industry. Minimum Bachelor's degree from a reputable university, preferably in a related field such as Pharmacy, Life Sciences, or Regulatory Affairs.

· Proficient in time management, MS Office suite. Exposure to Slack, Monday & to Compliance software like QMS Express, is desirable.

· Strong organizational skills with the ability to multitask, Excellent problem-solving, decision-making abilities and Strong interpersonal and communication skills.

Benefits:

· Work from home

· Annual Bonus

· Opportunity to work with a dynamic team in a growing company

· UK time/ shift (10am - 7pm)

· Professional development & growth opportunities

Gravitiq is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Job Type: Full-time

Benefits:

• Work from home

Schedule:

• Monday to Friday

Supplemental Pay:

• Performance bonus

Application Question(s):

• Do you have experience on SUPPLEMENTS category?

Experience:

• Regulatory: 3 years (Preferred)

Work Location: In person