Precision Medical is currently recruiting for a Regulatory Affairs Specialist. The position requires participation in and leadership to achieve and maintain compliance with FDA 21 CFR 800-1299, CGMP audits, 510(k) submissions, product complaints, CE registration, ISO 13485:2016, and CMDCAS/MDSAP. The Regulatory Affairs Specialist will coordinate communications with outside agencies, auditors, and notified bodies.
This position is based in Northampton, PA. Candidate must reside within commuting distance to the corporate headquarters. This position is open to U.S. Workers Only. A U.S. Worker is someone who is either a U.S. Citizen, U.S. National, U.S. Lawful Permanent Resident, or a person granted Refugee or Asylum status by the U.S. Government. Precision Medical will not sponsor a foreign national for this position.
- Interpret FDA and International regulations as they apply to products, processes, and procedures.
- Maintain product compliance to current standards and regulations.
- Assist in the creation and maintenance of product technical files.
- Coordinate Supplier/Distributor documentation in accordance with regulatory requirements.
- Create a program to implement CE Marking in accordance with applicable regulatory requirements.
- Prepare, submit, and manage Technical Files in accordance with regulatory requirements.
- Review critical documents submitted to regulatory agencies.
- Lead post market surveillance activity, obtain objective evidence, and prepare summary reports.
- Ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
- Create and/or review documentation to ensure communications convey all necessary details and adhere to applicable regulatory standards on a global basis.
- Assist in investigation and resolve compliance non-conformances.
- Formulate/implement regulatory policies and procedures that maintain or enhance compliance.
- Train staff in regulatory policies and procedures.
- Develop and perform both internal and external audits in accordance with regulatory requirements.
- Customize documentation upon request of foreign government agencies and customer request.
- 3-5 years experience: regulatory, medical devices.
- Working knowledge of FDA 21 CFR parts 800 to 1299, ISO 13485:2016, CE, and CMDCAS/MDSAP.
- Ability to qualify suppliers and implement controls.
- Internal Audit experience; MDSAP Certification preferred.
- Proficiency in ERP system, Microsoft Office, and all related applications.
- Commitment to excellence, high standards, and acute attention to detail.
- Excellent written and oral communication skills.
- Ability to build relationships across diverse workgroups.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Demonstrated ability to plan and organize projects.
- Good judgement with the ability to make timely and sound decisions.
Precision Medical, Inc. is a Federal Contractor and an Equal Opportunity Employer. Veterans, Females and Minorities are encouraged to apply. EOE Minorities/Females/Disabled/Vet
To apply to this position:
Download and fill out our Employment Application and the EEO and Veterans Self Identification Forms.
Once completed, email the application to firstname.lastname@example.org.