Regulatory Affairs Manager

Acumed LLC

Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope

The Regulatory Manager/PMS (RM) is responsible for the oversight of the Post Market Surveillance and Clinical Regulatory Affairs team. The RM provides regulatory leadership and ensures compliance with all regulatory requirements with regards to PMS and clinical applications including submissions, managing departmental projects, customer complaints, Medical Device Reporting/Vigilance Reporting/and Adverse Event reporting, interacting with governmental agencies, and directing and managing department employees. Understand business needs and implement an aligned strategic plan. The RM provides leadership and direction in the creation and implementation of Regulatory policies, procedures, and strategies.

Responsibilities

1. With executive oversight and approval, establish and execute strategic plan for Regulatory Affairs.
2. Manage systems for documenting, reporting, investigating, and closing customer complaints.
3. Manage the clinical regulatory affairs team with oversight on the CERs.
4. Ensure timely reporting of adverse events globally.
5. Provide guidance on HHE teams to determine any field action.
6. Assign Regulatory Specialists to ensure proper and timely reporting.
7. Initiate and maintain accurate PSURs, PMSP/C.
8. Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative.
9. Manage field actions including but not limited to product recalls.
10. Help develop annual operating budget and manage activities to achieve expected budget performance.
11. Develop and train staff to ensure appropriate skills/behaviors are present to achieve strategic objectives; perform annual performance reviews for direct reports.

Qualifications

1. Bachelor’s degree in life sciences, engineering or related field required, master’s degree preferred.
2. 6 to 8 years of experience in a Regulatory Affairs capacity requirement, prior leadership/management experience in regulatory environment preferred.
3. Regulatory Affairs Certification preferred.
4. Experience in implantable medical device manufacturing required.
5. Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards.
6. Ability to liaise and interact with product development team members with a strong understanding of the product development process.
7. Ability to manage timelines.
8. Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
9. Extensive knowledge and experience in implementation of Six Sigma quality concepts and techniques.
10. Familiarity with Lean Manufacturing concepts.
11. Knowledge and experience with ERP systems and their applications, SAP preferred.
12. Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook).

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.